Every device in our catalog, checked by name and by manufacturer against three public FDA/NLM databases. Here's exactly what each search found.
We checked 14 devices in this catalog against FDA's 510(k), GUDID, and Registration & Listing databases: 6 verified under the retail name, 3 verified under a different name, 1 with unmatched records, 2 with no record found, and 2 outside this device category. Registry searches run through Oct 5, 2026.
Where a registry record exists, the company on file is never the retail brand - it's the contract manufacturer or specification developer behind the device.
| Retail brand | Name on registry record | Applicant on file |
|---|---|---|
| CurrentBody | CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Omnilux | faceLITE | Ismart Marketing Svcs, Ltd. |
| Dr. Dennis Gross | Not matched to a specific record | LED TECHNOLOGIES INC |
| MZ Skin | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin |
| Qure | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. |
| Aphrona | PDT-FACE | Beijing Adss Development Co., Ltd. |
| Therabody | TheraFace Mask | Therabody, Inc. |
| Ulike | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. |
| Shark | CryoGlow (FW3XXXX) | Sharkninja Operating, LLC |
| Solawave | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development Co., Ltd. |
In every case above, the applicant of record is not the name the device is sold under.
Cleared as CurrentBody Skin LED Light Therapy Mask Series 2, model MK-90H. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
Checked Aug 15, 2026
The GUDID record for Contour Face cites K191629. That clearance was issued for a device named faceLITE, applicant Ismart Marketing Svcs, Ltd.
Checked Aug 15, 2026
The GUDID record under this device name is marked not in commercial distribution since 2024-02-12. Four active records from the same manufacturer carry no device description, catalogue number or GTIN, so the device sold today cannot be matched to a specific record.
Checked Aug 15, 2026
No record found under the device name Illumina in any of the three databases. All iRestore clearances located relate to hair growth devices.
Checked Aug 14, 2026
No records found in any of the three databases - see the search log in Methodology below.
The product page for Illumina carries a circular seal reading "CLEARED TECHNOLOGY," styled to match adjacent IEC and ISO seals. The image is labelled "Icon for FDA Cleared Technology" in the page source. No clearance number or footnote appears alongside it.
Two things sit oddly next to that seal. The same manufacturer's hair growth device, iRESTORE Elite, carries a different badge - plain text reading "FDA-Cleared" - and clearances for that product line do appear in the databases. And Illumina's own technical specifications table lists its certifications as "IEC Safety Tested, ISO Quality Assured," with no FDA line at all.
Not a LED mask. No record identified.
Checked Aug 14, 2026
No records found in any of the three databases - see the search log in Methodology below.
Listed in FDA Registration & Listing as Massager, Therapeutic, Electric - a different regulatory category from over-the-counter light-based devices.
Checked Aug 14, 2026
Exact device-name match. Applicant is Mz Skin (the retail brand itself), London GB.
Checked Aug 17, 2026
No 510(k), GUDID, or Registration & Listing record for a Medisana LED face mask. Medisana USA, Inc. does hold one unrelated 510(k) (K002153, an ultrasonic nebulizer, 2001): different device entirely. Medisana GmbH has several GUDID records (pulse oximeter, blood pressure monitor, ear thermometer, neck massager, massage mat, shiatsu cushion) but none is a face mask. Registration & Listing proprietary-name search for 'Medisana' returns 9 establishments; the closest adjacent hits are contract manufacturer Zhangzhou Easepal, which lists 'Medisana:Red Light Mat LP 300' / 'Red Light Pad LP 100/LP200' (a different, non-mask red-light product line) and 'Medisana:SLEEP MASK SM 500' (a heating pad, not a light-therapy device). Neither is the 336-LED face mask in this catalog.
Checked Aug 17, 2026
Exact device-name match. Applicant is Light Tree Ventures Europe B.V. (Netherlands), the OEM, not 'Qure Skincare' as named on the Amazon listing, but this is the normal applicant/retail-brand split seen elsewhere in this catalog (e.g. CurrentBody). Verbatim listing claim 'First FDA-cleared' is confirmed.
Checked Aug 17, 2026
The 510(k) K192295 was cleared under the device name 'PDT-FACE', applicant Beijing Adss Development Co., Ltd., not 'Aphrona' or 'MOONLIGHT PRO'. Registration & Listing connects the two: Beijing Adss's own registration (3007084556) lists 'Aphrona LED Facial Mask' as a proprietary name under the identical pair of product codes (OLP/OHS) as K192295. No model-specific name ties this to 'MOONLIGHT PRO' specifically (Aphrona may sell more than one LED mask under this manufacturer), so this is recorded as verified-different-name, not verified. A separate manufacturer (Shenzhen Siken 3D Technology, reg. 3007744197) registers unrelated Aphrona-branded EMS/galvanic devices; not connected to this light mask. Verbatim listing claim 'FDA 510(k) cleared as a Class II medical device' is supported by this record.
Checked Aug 17, 2026
The 510(k) K230293 was cleared under the device name 'TheraFace Mask' (base variant, 648 LEDs per its own GUDID listing), not 'TheraFace Mask Glo' (504 LEDs, a separate GUDID DI). No 510(k) device-name search returns a record literally named 'TheraFace Mask Glo'. Registration & Listing closes the gap: Therabody's own registration (3012386142) lists 'TheraFace Mask; TheraFace Mask Glo' together, under the identical pair of product codes (OHS/OLP) as K230293. Both GUDID DIs (base and Glo) leave the 'FDA Premarket Submission Number' field as 'Not Available/Not Released', so GUDID itself doesn't confirm the link either way. The Registration & Listing pairing is the strongest evidence found. Verbatim listing claim 'FDA Cleared' is supported for the product family, not confirmed model-for-model against Glo's own LED count.
Checked Aug 17, 2026
Exact match on applicant (Shenzhen Ulike Smart Electronics Co., Ltd., same name given for this product in the source table) and model number (UM10) across 510(k), GUDID, and Registration & Listing.
Checked Aug 17, 2026
510(k) device name 'CryoGlow (FW3XXXX)' uses a wildcard model pattern that covers FW312PL; GUDID has a DI for that exact model number under SharkNinja Operating LLC. Verbatim listing claim 'FDA-cleared' is confirmed. The 510(k) filing (read 2026-10-05) lists red 630 ±10nm, blue 415 ±10nm and IR 830 ±10nm, 480 LEDs in 160 tri-wick packages; sharkninja.com's own '630nm' figure for blue is not supported by the filing.
Checked Oct 5, 2026
Exact device-name match. The 510(k) K252983 was issued for 'Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)', applicant Shenzhen Goodwind Technology Development Co., Ltd., the OEM; GUDID lists 'Solawave Wrinkle Retreat Pro Light Therapy Face Mask', model PH-m03, under the same company. Solawave's retail SKU 61137-T does not appear in GUDID; the match rests on the device name, the four wavelengths and the 3-minute treatment, which are the same in the filing and on solawave.co.
Checked Oct 5, 2026
Three public databases, checked directly - never through an aggregator.
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
30 searches logged for this catalog
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
18 searches logged for this catalog
73 searches run across all 14 devices - including every search that came back empty. A "no record found" status means we ran the searches and logged the result, not that we stopped looking.
Several devices in this catalog carry product code OHS - the FDA classification covering over-the-counter light-based wrinkle reduction - a Class II designation that requires a 510(k) submission. Two routes exist for selling a light-emitting skincare device without one, and neither is generally open to a device marketed with wrinkle-reduction or collagen claims: FDA treats those as structure-or-function claims rather than cosmetic ones, and its general wellness policy separately excludes light- and laser-based technology from the low-risk category regardless of how the claims are worded.
That leaves two possibilities we can't tell apart from outside the agency's databases when a search under a device's retail name comes back empty. A clearance may exist under a different device name, applicant, or corporate entity than the ones we searched - this is common, and the table above shows exactly that pattern: Omnilux Contour Face's clearance is filed under the name faceLITE. Or no submission was made under any name we found.
We are not a regulator and we are not making a determination about any device's legal status. What we can report is the search itself - which databases, which terms, and what came back. See each device's card above for its specific searches and results.
An FDA clearance record is not an endorsement of how well a device works - 510(k) clearance means a device was found substantially equivalent to an existing legally marketed device, not that FDA evaluated or confirmed its real-world results.
We are not a regulatory body. Nothing on this page is a regulatory determination, and it isn't legal or medical guidance - it's a record of what we found searching public FDA and NLM databases, and how we searched.
Registry data changes. Every record and every search above carries its own checked date - treat anything without a recent date as due for a recheck.