Retail-to-record matching
FDA lineage
Documentary differences publish as source facts. A potentially adverse interpretation remains withheld while identity is checked for 24–48 hours; no regulatory conclusion is inferred from a description difference.
direct8
probable3
ambiguous2
no match19
| Retail SKU | Identity confidence | K-number | Documentary difference | Source locus / status |
|---|---|---|---|---|
| Dr. Dennis Gross DRx SpectraLite FaceWare Pro | probable | K183247 | Retail listing and FDA file differ on brand, trade_name documentary_difference | record dated 2019-03-14 summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity check pending Applicant LED Technologies and the 415/605/630/660/880 nm profile align; Subject trade name dpl Faceware does not match the retail model name. Source |
| Kiierr 148 Pro Laser Cap | no_match | not found | none recorded | не найдено по терминам Kiierr 148 Pro Laser Cap на 2026-09-06 no extracted characteristic identity checked by Source |
| Omnilux Clear | direct | K210948 | Retail listing and FDA file differ on wavelengths documentary_difference | record dated 2021-06-24 summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex AccessGUDID DI 05060534510234 lists Omnilux CLEAR model TN2112 and FDA submission K210948; the retail trade name matches. Source |
| CurrentBody Skin LED Face Mask Series 1 | no_match | not found | none recorded | не найдено по терминам CurrentBody Skin LED Face Mask Series 1 на 2026-09-06 no extracted characteristic identity checked by Source |
| Omnilux Contour Face | direct | K191629 | Retail listing and FDA file differ on trade_name, wavelengths documentary_difference | record dated 2019-09-12 summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex AccessGUDID DI 05060534510128 lists Omnilux Contour FACE model TN19G and FDA submission K191629; the retail trade name matches. Source |
| Therabody TheraFace Mask | direct | K230293 | none recorded | record dated 2023-06-09 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex FDA Subject and retail page both name TheraFace Mask; AccessGUDID DI 00840295401720 lists the same model and applicant. Source |
| Hooga Rechargeable Silicone LED Mask | no_match | not found | none recorded | не найдено по терминам Hooga Rechargeable Silicone LED Mask на 2026-09-06 no extracted characteristic identity checked by Source |
| Capillus Spectrum | no_match | not found | none recorded | не найдено по терминам Capillus Spectrum на 2026-09-06 no extracted characteristic identity checked by Source |
| Hooga Luma LED Face Mask | ambiguous | K253712 | Retail listing and FDA file differ on brand, model, wavelengths documentary_difference | record dated 2026-01-23 summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity check pending The retail page names HG-071 and cites K253712; the FDA Subject lists only RB-051/RB-061/RB-071/RB-052/RB-062/RB-072/RB-053/RB-063/RB-073. Source |
| CurrentBody Skin LED Face Mask Series 2 | direct | K250966 | Retail listing and FDA file differ on led_count, wavelengths documentary_difference | record dated 2025-06-25 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex FDA Subject model MK-90H has the exact CurrentBody Skin Series 2 trade name and the summary names CurrentBody.com Ltd as distributor; the retail page identifies Series 2. Source |
| dpl Flex Pad | no_match | not found | none recorded | не найдено по терминам dpl Flex Pad на 2026-09-06 no extracted characteristic identity checked by Source |
| iRESTORE Professional | no_match | not found | none recorded | не найдено по терминам iRESTORE Professional на 2026-09-06 no extracted characteristic identity checked by Source |
| Mito Red Light MitoQUAD Wavelength Belt | no_match | not found | none recorded | не найдено по терминам Mito Red Light MitoQUAD Wavelength Belt на 2026-09-06 no extracted characteristic identity checked by Source |
| Theradome EVO LH40 | no_match | not found | none recorded | не найдено по терминам Theradome EVO LH40 на 2026-09-06 no extracted characteristic identity checked by Source |
| Kiierr 272 Premier Laser Cap | no_match | not found | none recorded | не найдено по терминам Kiierr 272 Premier Laser Cap на 2026-09-06 no extracted characteristic identity checked by Source |
| Project E Beauty Lumamask Pro | probable | K214101 | Retail listing and FDA file differ on trade_name, model, led_count documentary_difference | record dated 2022-03-23 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity check pending Project E Beauty branding and all three wavelength bands align; FDA Subject is Project E Beauty LED Light Therapy Mask model PE730 while retail is Lumamask Pro. Source |
| Omnilux Men | ambiguous | K191629 | Retail listing and FDA file differ on trade_name, wavelengths documentary_difference | record dated 2019-09-12 summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity check pending Applicant/company and Omnilux product family align; GUDID DI 05060534510524 identifies Omnilux Men's model TN2227 while FDA Subject is faceLITE LED mask. Source |
| Solawave Wrinkle Retreat Pro LED Face Mask | direct | K252983 | none recorded | record dated 2025-12-17 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex FDA Subject and AccessGUDID DI 06956822893013 both identify Wrinkle Retreat Pro model PH-m03; the retail trade name matches. Source |
| Theradome PRO LH80 | no_match | not found | none recorded | не найдено по терминам Theradome PRO LH80 на 2026-09-06 no extracted characteristic identity checked by Source |
| Capillus PRO | probable | K160285 | Retail listing and FDA file differ on trade_name documentary_difference | record dated 2016-08-16 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity check pending Applicant Capillus and the 272-diode/650 nm profile align; FDA Subject is Capillus272 Pro while retail and GUDID DI 00853327006565 identify Capillus Pro. Source |
| HigherDOSE Red Light Face Mask | direct | K241933 | Retail listing and FDA file differ on trade_name documentary_difference | record dated 2024-09-13 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex AccessGUDID DI 00850049532471 lists HIGHERDOSE model MK66-L and FDA submission K241933; applicant and retail brand match. Source |
| Qure Q-Rejuvalight Pro | direct | K230042 | none recorded | record dated 2023-04-28 summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex AccessGUDID DI 08719327598719 lists Q-Rejuvalight Pro Facewear model P19-0023 and FDA submission K230042; the retail page cites the same K-number. Source |
| Dermalux Flex MD | no_match | not found | none recorded | не найдено по терминам Dermalux Flex MD на 2026-09-06 no extracted characteristic identity checked by Source |
| Project E Beauty LumaLux Face Pro | no_match | not found | none recorded | не найдено по терминам Project E Beauty LumaLux Face Pro на 2026-09-06 no extracted characteristic identity checked by Source |
| iRESTORE Illumina Face Mask | no_match | not found | none recorded | не найдено по терминам iRESTORE Illumina Face Mask на 2026-09-06 no extracted characteristic identity checked by Source |
| dpl Joint Wrap | no_match | not found | none recorded | не найдено по терминам dpl Joint Wrap на 2026-09-06 no extracted characteristic identity checked by Source |
| iRESTORE Essential | no_match | not found | none recorded | не найдено по терминам iRESTORE Essential на 2026-09-06 no extracted characteristic identity checked by Source |
| PlatinumLED BioMax 900 | no_match | not found | none recorded | не найдено по терминам PlatinumLED BioMax 900 на 2026-09-06 no extracted characteristic identity checked by Source |
| Skin Gym LED Pro Light Therapy Mask | no_match | not found | none recorded | не найдено по терминам Skin Gym LED Pro Light Therapy Mask на 2026-09-06 no extracted characteristic identity checked by Source |
| Shark CryoGlow FW312 | direct | K242796 | Retail listing and FDA file differ on sku_family documentary_difference | record dated 2024-11-27 summary_leds:page=reviewed;table=subject_device_characteristics;role=Subject|summary_wavelengths_nm:page=reviewed;table=subject_device_characteristics;role=Subject identity checked 2026-09-07 by orchestrator-review-codex Retail model FW312 falls within FDA Subject model family FW3XXXX; AccessGUDID DI 00622356642804 identifies Shark CryoGlow model FW312. Source |
| Kineon MOVE+ | no_match | not found | none recorded | не найдено по терминам Kineon MOVE+ на 2026-09-06 no extracted characteristic identity checked by Source |
| Skin Gym Wrinklit LED Face Mask | no_match | not found | none recorded | не найдено по терминам Skin Gym Wrinklit LED Face Mask на 2026-09-06 no extracted characteristic identity checked by Source |