[ { "id": "currentbody-series-2", "brand": "CurrentBody", "model": "Skin LED Mask Series 2", "waves": [ 633, 830, 1072 ], "waveText": "633 · 830 · 1072", "leds": "236", "irradiance": "≈30 mW/cm²", "session": "10 min", "minutes": 10, "fit": "Flexible silicone", "power": "Rechargeable controller", "regulatory": "FDA cleared · CE, as reported by LED Mask Specs", "price": "€481", "priceSource": "Manufacturer EU page, 31 Oct 2026", "source": "https://www.currentbody.com/products/currentbody-skin-led-light-therapy-mask-series-2", "note": "Manufacturer page confirms 236 LEDs, 633/830/1072 nm and 10-minute sessions (checked 31 Oct 2026). Irradiance is retained from LED Mask Specs. The price was rechecked on the manufacturer EU page on 31 Oct 2026.", "origin": "Manufacturer LED count, wavelengths, session and price; LED Mask Specs irradiance", "imageCredit": "Image: CurrentBody, from the manufacturer product page", "fda": { "k": "K250966", "date": "2025-06-25", "device": "CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)", "applicant": "Shenzhen Kaiyan Medical Equipment Co.", "match": "confirmed", "note": "The FDA record names this model.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the CurrentBody Series 2 have near-infrared light?", "Yes. It lists 830 and 1072 nm near-infrared alongside 633 nm." ], [ "Does the CurrentBody Series 2 have blue light for acne?", "No blue wavelength is listed. Its reported wavelengths are 633 · 830 · 1072 nm." ], [ "How long is a CurrentBody Series 2 session?", "The manufacturer lists 10 min. Follow the device’s manual for frequency and use limits." ], [ "Is the CurrentBody Series 2 FDA cleared?", "K250966 is the 510(k) record linked to it (fda record names this model), cleared on 25 Jun 2025. The FDA record names this model." ], [ "How strong is the CurrentBody Series 2?", "From its published irradiance (≈30 mW/cm²) and 10-minute session, the estimated dose is ≈18 J/cm² over 10 min. Recent mask trials used about 4–8 J/cm² per session; this is a calculation from claims, not a measurement." ], [ "Which studies used the CurrentBody Series 2’s wavelengths?", "Six of the 15 summarised studies used wavelengths it lists, for example why red light may calm inflammation: the mechanism review (2017). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/currentbody-series-2.jpg", "page": "https://ledtranslated.com/masks/currentbody-series-2/" }, { "id": "currentbody-series-3", "brand": "CurrentBody", "model": "Skin LED Face Mask Series 3", "waves": [ 415, 532, 590, 633, 830, 1072 ], "waveText": "415 · 532 · 590 · 633 · 830 · 1072", "leds": "750", "irradiance": "Not found on checked page", "session": "10 min", "minutes": 10, "fit": "Flexible silicone with chin strap", "power": "Rechargeable controller · app", "regulatory": "Not verified for this exact model in this review", "price": "£499.99", "priceSource": "Manufacturer UK page, 31 Oct 2026; EU page lists €589.99", "source": "https://www.currentbody.com/products/currentbody-skin-led-light-therapy-mask", "note": "Six wavelengths, four presets and app-customised treatments. The checked page does not supply a numeric irradiance; Series 2 output is not substituted.", "origin": "Manufacturer specifications", "imageCredit": "Image: CurrentBody, from the manufacturer product page", "fda": { "k": "K260715", "date": "2026-06-03", "device": "CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)", "applicant": "The Beauty Tech Group, Ltd.", "match": "possible", "note": "A recent CurrentBody mask clearance; the record does not say “Series 3”, so the match is unconfirmed.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the CurrentBody Series 3 have near-infrared light?", "Yes. It lists 830 and 1072 nm near-infrared alongside 415, 532, 590, 633 nm." ], [ "Does the CurrentBody Series 3 have blue light for acne?", "Yes. It lists 415 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a CurrentBody Series 3 session?", "The manufacturer lists 10 min. Follow the device’s manual for frequency and use limits." ], [ "Is the CurrentBody Series 3 FDA cleared?", "K260715 is the 510(k) record linked to it (possible match, unconfirmed), cleared on 3 Jun 2026. A recent CurrentBody mask clearance; the record does not say “Series 3”, so the match is unconfirmed." ], [ "How strong is the CurrentBody Series 3?", "It has no published irradiance on the checked page, so a dose cannot be estimated." ], [ "Which studies used the CurrentBody Series 3’s wavelengths?", "Ten of the 15 summarised studies used wavelengths it lists, for example leds in dermatology: what 31 randomised trials add up to (2018). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/currentbody-series-3.jpg", "page": "https://ledtranslated.com/masks/currentbody-series-3/" }, { "id": "dennis-gross-faceware", "brand": "Dr. Dennis Gross", "model": "DRx SpectraLite FaceWare Pro", "waves": [ 415, 630 ], "waveText": "415 · 630", "leds": "160¹", "irradiance": "Not found on checked page", "session": "3 min", "minutes": 3, "fit": "Rigid shell", "power": "Rechargeable; controller details not verified", "regulatory": "FDA cleared, manufacturer claim", "price": "US$455", "priceSource": "Manufacturer US page, 31 Oct 2026, confirmed", "source": "https://www.drdennisgross.com/drx-spectralite-faceware-pro-3-minute-led-device/695866568117.html", "note": "¹ Manufacturer lists 100 red + 60 blue lights, totalling 160, but the same page also says “up to 100 lights”. LED Mask Specs states 162. The page’s comparison table lists 630 nm red and 415 nm blue alongside 605 nm amber and 880 nm near-infrared, apparently across the brand’s device range; only red and blue are shown here.", "origin": "Manufacturer LED breakdown/session; baseline wavelengths", "imageCredit": "Image: Dr. Dennis Gross, from the manufacturer product page", "fda": { "k": "K183247", "date": "2019-03-14", "device": "dpl Faceware", "applicant": "Led Technologies, Inc.", "match": "possible", "note": "A “Faceware” device cleared for LED Technologies; the record does not name Dr. Dennis Gross or the Pro model.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the Dr. Dennis Gross FaceWare Pro have near-infrared light?", "No near-infrared wavelength is listed. Its reported wavelengths are 415 · 630 nm." ], [ "Does the Dr. Dennis Gross FaceWare Pro have blue light for acne?", "Yes. It lists 415 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a Dr. Dennis Gross FaceWare Pro session?", "The manufacturer lists 3 min. Follow the device’s manual for frequency and use limits." ], [ "Is the Dr. Dennis Gross FaceWare Pro FDA cleared?", "K183247 is the 510(k) record linked to it (possible match, unconfirmed), cleared on 14 Mar 2019. A “Faceware” device cleared for LED Technologies; the record does not name Dr. Dennis Gross or the Pro model." ], [ "How strong is the Dr. Dennis Gross FaceWare Pro?", "It has no published irradiance on the checked page, so a dose cannot be estimated." ], [ "Which studies used the Dr. Dennis Gross FaceWare Pro’s wavelengths?", "Four of the 15 summarised studies used wavelengths it lists, for example leds in dermatology: what 31 randomised trials add up to (2018). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/dennis-gross-faceware.jpg", "page": "https://ledtranslated.com/masks/dennis-gross-faceware/" }, { "id": "dr-renu-spectralift", "brand": "Dr. Renú", "model": "SpectraLift Advanced", "waves": [ 465, 530, 630, 660, 850 ], "waveText": "465 · 530 · 630–660 · 850", "leds": "280", "irradiance": "Up to 50 mW/cm², by mode", "session": "10–15 min", "minutes": 15, "fit": "Flexible silicone · 300 g", "power": "2000 mAh · USB-C", "regulatory": "US platform FDA cleared, brand claim; EU CE under LVD/RoHS, not MDR medical-device marking", "price": "€299", "priceSource": "Brand-supplied EU price, 31 Oct 2026", "source": "https://dr-renu.com/en-en/products/spectralift-led-face-mask", "note": "Values shown are nominal wavelengths. The manufacturer page now gives approximate channel peaks of 630 nm red, 458 nm blue, 517 nm green and 850 nm near-infrared, nine modes, and 10–15 minutes, 3–4 times weekly. Earlier figures listed a 26.9–50.0 mW/cm² mode range.", "origin": "Manufacturer specifications and price", "imageCredit": "Image: Dr. Renú, from the manufacturer product page", "fda": { "k": "K253712", "date": "2026-01-23", "device": "LED Light Therapy Mask (RB-051, RB-061, RB-071 and related models)", "applicant": "Shenzhen Rainbow Technology Co., Ltd.", "match": "model", "note": "Dr. Renú’s device documentation cites K253712 and model RB-061. The FDA record lists RB-061 among the covered models under the manufacturer’s name, not the brand name.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the Dr. Renú SpectraLift have near-infrared light?", "Yes. It lists 850 nm near-infrared alongside 465, 530, 630, 660 nm." ], [ "Does the Dr. Renú SpectraLift have blue light for acne?", "Yes. It lists 465 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a Dr. Renú SpectraLift session?", "The manufacturer lists 10–15 min. Follow the device’s manual for frequency and use limits." ], [ "Is the Dr. Renú SpectraLift FDA cleared?", "K253712 is the 510(k) record linked to it (matched by model number), cleared on 23 Jan 2026. Dr. Renú’s device documentation cites K253712 and model RB-061. The FDA record lists RB-061 among the covered models under the manufacturer’s name, not the brand name." ], [ "How strong is the Dr. Renú SpectraLift?", "From its published irradiance (Up to 50 mW/cm², by mode) and 15-minute session, the estimated dose is up to 45 J/cm² over 15 min. Recent mask trials used about 4–8 J/cm² per session; this is a calculation from claims, not a measurement." ], [ "Which studies used the Dr. Renú SpectraLift’s wavelengths?", "Ten of the 15 summarised studies used wavelengths it lists, for example how often should you use a red led mask? a sham-controlled trial (2025). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/dr-renu-spectralift.jpg", "page": "https://ledtranslated.com/masks/dr-renu-spectralift/" }, { "id": "nanoleaf-face-mask", "brand": "Nanoleaf", "model": "LED Light Therapy Face Mask", "waves": [ 460, 520, 525, 640, 850 ], "waveText": "460 · 520/525 · 640 · 850", "leds": "432", "irradiance": "78.4–103.1 mW/cm²", "session": "5–10 min recommended", "minutes": 10, "fit": "Flexible silicone · 258 g", "power": "2500 mAh rechargeable controller", "regulatory": "LED Mask Specs reports FDA/CE; not independently verified", "price": "US$249.99", "priceSource": "Manufacturer US reference/list price; sale excluded, 31 Oct 2026", "source": "https://nanoleaf.me/en-us/products/nanoleaf-light-therapy-face-mask", "note": "108 bulbs with four LEDs each. Manufacturer now lists output by mode and a 1–30 minute timer; recommended use is 5–10 minutes. Green is listed as 520 nm in one mode and 525 nm in blends. These update the older comparison snapshot. The 31 Oct 2026 page confirms 850 nm near-infrared in every colour mode and a 1–30 minute timer.", "origin": "Manufacturer specifications; baseline regulatory claim", "imageCredit": "Image: Nanoleaf, from the manufacturer product page", "fda": { "k": null, "date": null, "device": null, "applicant": null, "match": "none", "note": "No 510(k) record found under the brand or model name.", "checked": "2026-10-31", "productCode": null }, "faq": [ [ "Does the Nanoleaf Face Mask have near-infrared light?", "Yes. It lists 850 nm near-infrared alongside 460, 520, 525, 640 nm." ], [ "Does the Nanoleaf Face Mask have blue light for acne?", "Yes. It lists 460 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a Nanoleaf Face Mask session?", "The manufacturer lists 5–10 min recommended. Follow the device’s manual for frequency and use limits." ], [ "Is the Nanoleaf Face Mask FDA cleared?", "No 510(k) record was found under its brand or model name in the FDA database on 31 October 2026. Brand claim: LED Mask Specs reports FDA/CE; not independently verified." ], [ "How strong is the Nanoleaf Face Mask?", "From its published irradiance (78.4–103.1 mW/cm²) and 10-minute session, the estimated dose is 47–62 J/cm² over 10 min. Recent mask trials used about 4–8 J/cm² per session; this is a calculation from claims, not a measurement." ], [ "Which studies used the Nanoleaf Face Mask’s wavelengths?", "Seven of the 15 summarised studies used wavelengths it lists, for example red vs near-infrared light on healing skin grafts, in rats (2020). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/nanoleaf-face-mask.jpg", "page": "https://ledtranslated.com/masks/nanoleaf-face-mask/" }, { "id": "omnilux-contour", "brand": "Omnilux", "model": "Contour Face", "waves": [ 633, 830 ], "waveText": "633 · 830", "leds": "132", "irradiance": "≈30 mW/cm²", "session": "10 min", "minutes": 10, "fit": "Flexible silicone", "power": "Rechargeable controller", "regulatory": "FDA cleared for full-face wrinkles, manufacturer claim; CE · TGA as reported by LED Mask Specs", "price": "€453.75", "priceSource": "Manufacturer EU page, 31 Oct 2026", "source": "https://omniluxled.com/pages/help-center-products", "note": "Manufacturer help centre specifies approximately 30 mW/cm² for Contour Face. The remaining baseline fields and reference price come from LED Mask Specs.", "origin": "Manufacturer irradiance, price and FDA claim; LED Mask Specs baseline", "imageCredit": "Image: Omnilux, from the manufacturer product page", "fda": { "k": "K191629", "date": "2019-09-12", "device": "faceLITE", "applicant": "Ismart Marketing Svcs, Ltd.", "match": "possible", "note": "Omnilux cites K191629, but the FDA record lists the device as “faceLITE” from Ismart Marketing, not as Omnilux Contour.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the Omnilux Contour have near-infrared light?", "Yes. It lists 830 nm near-infrared alongside 633 nm." ], [ "Does the Omnilux Contour have blue light for acne?", "No blue wavelength is listed. Its reported wavelengths are 633 · 830 nm." ], [ "How long is a Omnilux Contour session?", "The manufacturer lists 10 min. Follow the device’s manual for frequency and use limits." ], [ "Is the Omnilux Contour FDA cleared?", "K191629 is the 510(k) record linked to it (possible match, unconfirmed), cleared on 12 Sept 2019. Omnilux cites K191629, but the FDA record lists the device as “faceLITE” from Ismart Marketing, not as Omnilux Contour." ], [ "How strong is the Omnilux Contour?", "From its published irradiance (≈30 mW/cm²) and 10-minute session, the estimated dose is ≈18 J/cm² over 10 min. Recent mask trials used about 4–8 J/cm² per session; this is a calculation from claims, not a measurement." ], [ "Which studies used the Omnilux Contour’s wavelengths?", "Six of the 15 summarised studies used wavelengths it lists, for example why red light may calm inflammation: the mechanism review (2017). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/omnilux-contour.jpg", "page": "https://ledtranslated.com/masks/omnilux-contour/" }, { "id": "shark-cryoglow", "brand": "Shark", "model": "CryoGlow FW312", "waves": [ 415, 630, 830 ], "waveText": "415 · 630 · 830", "leds": "160+²", "irradiance": "Not found on checked page", "session": "Programme-dependent; 8 min in baseline", "minutes": 8, "fit": "Rigid shell · under-eye cooling", "power": "Rechargeable; check regional manual", "regulatory": "FDA cleared · CE/UKCA, as reported by LED Mask Specs", "price": "US$349.99", "priceSource": "Manufacturer US page, 31 Oct 2026; LED Mask Specs EU reference €379.99", "source": "https://www.sharkninja.com/shark-cryoglow-red-blue-infrared-iqled-face-mask-under-eye-cooling---blue-frost/FW312.html", "note": "² LED Mask Specs reports 160+ multi-zone LEDs. Count, wavelengths and EU reference price have not been independently validated here. Programme duration varies; consult the FW312 manual.", "origin": "LED Mask Specs baseline; manufacturer page consulted", "imageCredit": "Image: Shark, from the manufacturer product page", "fda": { "k": "K242796", "date": "2024-11-27", "device": "CryoGlow (FW3XXXX)", "applicant": "SharkNinja Operating, LLC", "match": "confirmed", "note": "The FDA record names the CryoGlow model family.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the Shark CryoGlow have near-infrared light?", "Yes. It lists 830 nm near-infrared alongside 415, 630 nm." ], [ "Does the Shark CryoGlow have blue light for acne?", "Yes. It lists 415 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a Shark CryoGlow session?", "The manufacturer lists Programme-dependent; 8 min in baseline. Follow the device’s manual for frequency and use limits." ], [ "Is the Shark CryoGlow FDA cleared?", "K242796 is the 510(k) record linked to it (fda record names this model), cleared on 27 Nov 2024. The FDA record names the CryoGlow model family." ], [ "How strong is the Shark CryoGlow?", "It has no published irradiance on the checked page, so a dose cannot be estimated." ], [ "Which studies used the Shark CryoGlow’s wavelengths?", "Ten of the 15 summarised studies used wavelengths it lists, for example leds in dermatology: what 31 randomised trials add up to (2018). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/shark-cryoglow.jpg", "page": "https://ledtranslated.com/masks/shark-cryoglow/" }, { "id": "silkn-mask-100", "brand": "Silk’n", "model": "LED Face Mask 100", "waves": [ 463, 592, 633 ], "waveText": "463 · 592 · 633", "leds": "100", "irradiance": "13.23–89.68 mW/cm²", "session": "10 min; page also lists 15 min", "minutes": 10, "fit": "Semi-rigid, baseline description", "power": "Rechargeable controller", "regulatory": "CE cosmetic-device claim in baseline; FDA status not verified", "price": "€160", "priceSource": "Manufacturer EU page, 31 Oct 2026", "source": "https://www.silkn.de/en/led-masks/led-face-mask-100-SILK000011.html", "note": "Manufacturer lists red 25.04, blue 89.68, yellow 13.23 and purple 77.95 mW/cm². Purple blends red and blue. This corrects the baseline’s missing-output label. Measurement conditions are not harmonised across brands.", "origin": "Manufacturer wavelengths, output, LED count and price; baseline remaining fields", "imageCredit": "Image: Silk’n, from the manufacturer product page", "fda": { "k": null, "date": null, "device": null, "applicant": null, "match": "none", "note": "Silk’n has other 510(k) clearances, but none found for this mask.", "checked": "2026-10-31", "productCode": null }, "faq": [ [ "Does the Silk’n Face Mask 100 have near-infrared light?", "No near-infrared wavelength is listed. Its reported wavelengths are 463 · 592 · 633 nm." ], [ "Does the Silk’n Face Mask 100 have blue light for acne?", "Yes. It lists 463 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a Silk’n Face Mask 100 session?", "The manufacturer lists 10 min; page also lists 15 min. Follow the device’s manual for frequency and use limits." ], [ "Is the Silk’n Face Mask 100 FDA cleared?", "No 510(k) record was found under its brand or model name in the FDA database on 31 October 2026. Brand claim: CE cosmetic-device claim in baseline; FDA status not verified." ], [ "How strong is the Silk’n Face Mask 100?", "From its published irradiance (13.23–89.68 mW/cm²) and 10-minute session, the estimated dose is 8–54 J/cm² over 10 min. Recent mask trials used about 4–8 J/cm² per session; this is a calculation from claims, not a measurement." ], [ "Which studies used the Silk’n Face Mask 100’s wavelengths?", "One of the 15 summarised studies used wavelengths it lists, for example red light and collagen density: a 136-person controlled trial (2014). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/silkn-mask-100.jpg", "page": "https://ledtranslated.com/masks/silkn-mask-100/" }, { "id": "light-salon-boost", "brand": "The Light Salon", "model": "Boost LED Face Mask (Boost Advanced)", "waves": [ 633, 830 ], "waveText": "633 · 830", "leds": "112", "irradiance": "≈30 mW/cm², baseline", "session": "10 min", "minutes": 10, "fit": "Flexible silicone", "power": "Rechargeable battery pack", "regulatory": "FDA cleared for fine lines and wrinkles, manufacturer claim; K191629 · CE as reported by LED Mask Specs", "price": "€450", "priceSource": "Manufacturer EU page, 31 Oct 2026", "source": "https://www.thelight-salon.com/products/boost-led-face-mask", "note": "The manufacturer now sells this as the Boost LED Face Mask: 633 nm red + 830 nm near-infrared, 10-minute sessions, €450. LED Mask Specs lists it as Boost Advanced with 56 red and 56 near-infrared LEDs; the LED count was not found on the current page.", "origin": "Manufacturer wavelengths, session, price and FDA claim; LED Mask Specs LED count and output", "imageCredit": "Image: The Light Salon, from the manufacturer product page", "fda": { "k": null, "date": null, "device": null, "applicant": null, "match": "none", "note": "No 510(k) record found under the brand or model name.", "checked": "2026-10-31", "productCode": null }, "faq": [ [ "Does the The Light Salon Boost have near-infrared light?", "Yes. It lists 830 nm near-infrared alongside 633 nm." ], [ "Does the The Light Salon Boost have blue light for acne?", "No blue wavelength is listed. Its reported wavelengths are 633 · 830 nm." ], [ "How long is a The Light Salon Boost session?", "The manufacturer lists 10 min. Follow the device’s manual for frequency and use limits." ], [ "Is the The Light Salon Boost FDA cleared?", "No 510(k) record was found under its brand or model name in the FDA database on 31 October 2026. Brand claim: FDA cleared for fine lines and wrinkles, manufacturer claim; K191629 · CE as reported by LED Mask Specs." ], [ "How strong is the The Light Salon Boost?", "From its published irradiance (≈30 mW/cm², baseline) and 10-minute session, the estimated dose is ≈18 J/cm² over 10 min. Recent mask trials used about 4–8 J/cm² per session; this is a calculation from claims, not a measurement." ], [ "Which studies used the The Light Salon Boost’s wavelengths?", "Six of the 15 summarised studies used wavelengths it lists, for example why red light may calm inflammation: the mechanism review (2017). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/light-salon-boost.jpg", "page": "https://ledtranslated.com/masks/light-salon-boost/" }, { "id": "therabody-glo", "brand": "Therabody", "model": "TheraFace Mask Glo", "waves": [ 415, 633, 830 ], "waveText": "415 · 633 · 830", "leds": "504", "irradiance": "Not found on checked page", "session": "12 min full routine", "minutes": 12, "fit": "Rigid polymer housing · 514 g", "power": "Cordless rechargeable · scalp vibration", "regulatory": "FDA cleared · CE, as reported by LED Mask Specs", "price": "€349", "priceSource": "Manufacturer EU page, 31 Oct 2026", "source": "https://www.therabody.eu/en/products/theraface-mask-glo-led-light-mask", "note": "Manufacturer confirms 504 LEDs, 415/633/830 nm and a 12-minute routine. Individual treatments run 4–12 minutes. Materials are PC/ABS and TPU; the original source’s semi-rigid description is replaced.", "origin": "Manufacturer specifications; baseline price/regulatory claim", "imageCredit": "Image: Therabody, from the manufacturer product page", "fda": { "k": "K230293", "date": "2023-06-09", "device": "TheraFace Mask", "applicant": "Therabody, Inc.", "match": "possible", "note": "The record is for the TheraFace Mask; it does not name the newer Mask Glo.", "checked": "2026-10-31", "productCode": "OHS" }, "faq": [ [ "Does the Therabody Mask Glo have near-infrared light?", "Yes. It lists 830 nm near-infrared alongside 415, 633 nm." ], [ "Does the Therabody Mask Glo have blue light for acne?", "Yes. It lists 415 nm blue light. Acne trials mostly used 415 nm blue with red light." ], [ "How long is a Therabody Mask Glo session?", "The manufacturer lists 12 min full routine. Follow the device’s manual for frequency and use limits." ], [ "Is the Therabody Mask Glo FDA cleared?", "K230293 is the 510(k) record linked to it (possible match, unconfirmed), cleared on 9 Jun 2023. The record is for the TheraFace Mask; it does not name the newer Mask Glo." ], [ "How strong is the Therabody Mask Glo?", "It has no published irradiance on the checked page, so a dose cannot be estimated." ], [ "Which studies used the Therabody Mask Glo’s wavelengths?", "Ten of the 15 summarised studies used wavelengths it lists, for example leds in dermatology: what 31 randomised trials add up to (2018). A wavelength match does not mean the mask reproduces a study’s dose or results." ] ], "image": "https://ledtranslated.com/img/therabody-glo.jpg", "page": "https://ledtranslated.com/masks/therabody-glo/" } ]