FDA Product Code
FDA Product Code OHS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 163 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221430 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | 2022-07-27 | Special | PDF ↗ |
| K220064 | Synergy Marble (Model: Opasm) | Yrs Group, Inc. | 2022-07-22 | Traditional | PDF ↗ |
| K221151 | Beauty LED Mask, Model: KFB265 | Hunan Guangye Biotechnology Co., Ltd. | 2022-07-19 | Traditional | PDF ↗ |
| K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO , Ltd. | 2022-05-17 | Traditional | PDF ↗ |
| K212947 | Trinity Plus Wrinkle Reducer | Carol Cole Company Dba Nuface | 2022-04-02 | Traditional | PDF ↗ |
| K214101 | Project E Beauty LED Light Therapy Mask (Model: PE730) | Duplex International Trading Limited | 2022-03-23 | Traditional | PDF ↗ |
| K210823 | LYMA Laser | Lyma Life , Ltd. | 2022-03-18 | Traditional | PDF ↗ |
| K213285 | easy Claire | Y & J Bio Co., Ltd. | 2022-03-03 | Traditional | PDF ↗ |
| K212771 | LightStim Elipsa | Led Intellectual Properties, LLC | 2022-01-26 | Traditional | PDF ↗ |
| K213841 | ENEO TOTALE (Model: ENEOT947) | Premier North America, Inc. | 2022-01-06 | Special | PDF ↗ |
| K213024 | Oren LED Perioral Light Therapy System | Shenzhen Kaiyan Medical CO , Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K212155 | TheraFace LED | Theragun, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K210965 | reVive Light Therapy Essentials | Led Technologies, Inc. | 2021-12-15 | Traditional | PDF ↗ |
| K212275 | Dermalux Flex MD | Aesthetic Technology, Ltd. | 2021-11-18 | Traditional | PDF ↗ |
| K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-14 | Traditional | PDF ↗ |
| K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine | Ningbo Hesi Electric Co., Ltd. | 2021-07-14 | Traditional | PDF ↗ |
| K210954 | Synergy | Yrs Group, Inc. | 2021-06-29 | Traditional | PDF ↗ |
| K202442 | Carewear Firefly Wrinkle Reduction | Carewear Corp. | 2020-11-19 | Traditional | PDF ↗ |
| K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro) | Gtg Wellness Co., Ltd. | 2020-06-22 | Traditional | PDF ↗ |
| K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019-09-12 | Traditional | PDF ↗ |
| K190443 | MMSphere | Galactic Beauty, LLC | 2019-06-24 | Traditional | PDF ↗ |
| K183247 | dpl Faceware | Led Technologies, Inc. | 2019-03-14 | Traditional | PDF ↗ |
| K183671 | LG PRA.L DERMA LED MASK | Lg Electronics.Inc | 2019-01-22 | Special | PDF ↗ |
| K180875 | POLY REJUV | Medtek Skincare, LLC | 2018-09-14 | Traditional | PDF ↗ |
| K181659 | Avologi ENEO | Premier North America, Inc. | 2018-07-26 | Traditional | PDF ↗ |
| K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018-06-19 | Traditional | PDF ↗ |
| K172909 | ELEVARE, PERFECTIO 4 | Omm Imports D/B/A Zero Gravity | 2018-06-07 | Traditional | PDF ↗ |
| K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System | Led Technologies, Inc. | 2018-05-15 | Traditional | PDF ↗ |
| K180320 | dpl IIa Panel | Led Technologies, Inc. | 2018-04-03 | Traditional | PDF ↗ |
| K172662 | reVive Perioral | Led Technologies, Inc. | 2018-01-09 | Traditional | PDF ↗ |
| K171323 | BIOPHOTAS CELLUMA3 | Biophotas, Inc. | 2017-09-01 | Traditional | PDF ↗ |
| K170984 | LG BEAUTY LED MASK | Lg Electronics | 2017-08-23 | Traditional | PDF ↗ |
| K171386 | dpl SpectraLite | Led Technologies, Inc. | 2017-08-07 | Traditional | PDF ↗ |
| K171390 | dpl II Panel | Led Technologies, Inc. | 2017-08-03 | Traditional | PDF ↗ |
| K163137 | NIRA Beauty Skin Laser | Dermal Photonics Corporation | 2017-07-12 | Traditional | PDF ↗ |
| K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017-04-14 | Traditional | PDF ↗ |
| K162784 | Silk'n HST | Home Skinovations , Ltd. | 2017-03-25 | Traditional | PDF ↗ |
| K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2017-01-13 | Traditional | PDF ↗ |
| K161849 | Bright | Tanda Beauty Canada, Inc. | 2016-07-29 | Special | PDF ↗ |
| K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | 2016-02-25 | Traditional | PDF ↗ |
| K151337 | Strialite | Centre Light Solutions, LLC | 2016-02-24 | Traditional | PDF ↗ |
| K151336 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | 2015-10-23 | Traditional | PDF ↗ |
| K150098 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | 2015-04-09 | Traditional | PDF ↗ |
| K141181 | NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES | Led Technologies, LLC | 2015-03-31 | Traditional | PDF ↗ |
| K140471 | PRO X OTC 5 | La Lumiere, LLC | 2015-01-15 | Traditional | PDF ↗ |
| K133896 | REJUVALITE MD | Trophy Skin, Inc. | 2014-11-13 | Traditional | PDF ↗ |
| K141308 | NUTRA LIGHT RED | Nutra Luxe MD, LLC | 2014-08-20 | Traditional | PDF ↗ |
| K133546 | STARLITE-OM, LIGHT EFFECTS, THIBIANT | Ps Advanced Engineering | 2014-08-06 | Traditional | PDF ↗ |
| K132613 | SONILASE LIGHT THERAPY DEVICE | Biorenew Labs, LLC | 2014-02-05 | Traditional | PDF ↗ |
| K133473 | ILUMINAGE SKIN SMOOTHING LASER | Cynosure, Inc. | 2014-01-15 | Special | PDF ↗ |
| K124064 | YOUNG AGAIN | Espansione Marketing S.P.A | 2013-12-19 | Traditional | PDF ↗ |
| K130225 | QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE | Silverbay, LLC, D/B/A Quasar Bio-Tech | 2013-07-11 | Traditional | PDF ↗ |
| K120560 | TRINITY WRINKLE REMOVER | Carol Cole Company | 2012-11-06 | Traditional | PDF ↗ |
| K112362 | C100 WRINKLE REDUCTION DEVICE | Silver Bay, LLC | 2012-08-14 | Traditional | PDF ↗ |
| K111454 | ILUMINAGE DIODE LASER | Cynosure, Inc. | 2012-07-05 | Traditional | PDF ↗ |
| K120775 | LIGHT FOR WRINKLES | Led Intellectual Properties, LLC | 2012-06-04 | Traditional | PDF ↗ |
| K110301 | SILK'N FX | Home Skinovations , Ltd. | 2011-08-19 | Traditional | PDF ↗ |
| K110735 | TANDA MAX OTC SYSTEM | Pharos Life Corporation | 2011-08-03 | Traditional | PDF ↗ |
| K101382 | DPL NUVE | Led Technologies, LLC | 2010-11-09 | Traditional | PDF ↗ |
| K101190 | LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC | Led Intellectual Properties, LLC | 2010-07-01 | Traditional | PDF ↗ |
| K092460 | STAR-LITE -LM, MODEL SL8809 | Ps Advanced Engineering | 2010-03-05 | Traditional | PDF ↗ |
| K072459 | OMNILUX NEW-U | Photo Therapeutics, Inc. | 2008-03-03 | Traditional | PDF ↗ |
| K062991 | GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE | Light Bioscience, LLC | 2008-02-15 | Traditional | PDF ↗ |
Product code OHS · Class II · General, Plastic Surgery. Data: openFDA.