Panels › General, Plastic Surgery › Product code OHS · Class 2
Light Based Over The Counter Wrinkle Reduction
Regulation 878.4810
37510(k)s in 12 months (165 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in OHS
| Company | 510(k)s | Recalls |
|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 15 | 0 |
| Led Technologies, Inc. | 11 | 0 |
| Light Tree Ventures Europe B.V. | 7 | 0 |
| Led Intellectual Properties, LLC | 6 | 0 |
| Guangdong Newdermo Biotech Co., Ltd. | 4 | 0 |
| Foreo, Inc. | 3 | 0 |
| iSMART Developments, Ltd. | 3 | 0 |
| Premier North America, Inc. | 3 | 0 |
| Quasar Bio-Tech, Inc. | 0 | 3 |
| Shenzhen Kaiyan Medical CO , Ltd. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 17, 2022 | K223278 | easy Claire Y & J Bio Co., Ltd., KR | OHS |
| Nov 3, 2022 | K222377 | Led Mask Platinum Md Cellreturn Co., Ltd., KR | OHS |
| Jul 27, 2022 | K221430 | reVive Light Therapy LED Cleansing System Led Technologies, Inc. | OHS |
| Jul 22, 2022 | K220064 | Synergy Marble (Model: Opasm) Yrs Group, Inc. | OHS |
| Jul 19, 2022 | K221151 | Beauty LED Mask, Model: KFB265 Hunan Guangye Biotechnology Co., Ltd., CN | OHS |
| May 17, 2022 | K220168 | Skin Care Beauty Mask (Model: MJ-06) Shenzhen Kaiyan Medical CO , Ltd., CN | OHS |
| Apr 2, 2022 | K212947 | Trinity Plus Wrinkle Reducer Carol Cole Company Dba Nuface | OHS |
| Mar 23, 2022 | K214101 | Project E Beauty LED Light Therapy Mask (Model: PE730) Duplex International Trading Limited, CN | OHS |
| Mar 18, 2022 | K210823 | LYMA Laser Lyma Life , Ltd., GB | OHS |
| Mar 3, 2022 | K213285 | easy Claire Y & J Bio Co., Ltd., KR | OHS |
| Jan 26, 2022 | K212771 | LightStim Elipsa Led Intellectual Properties, LLC | OHS |
| Jan 6, 2022 | K213841 | ENEO TOTALE (Model: ENEOT947) Premier North America, Inc. | OHS |
| Dec 22, 2021 | K213024 | Oren LED Perioral Light Therapy System Shenzhen Kaiyan Medical CO , Ltd., CN | OHS |
| Dec 21, 2021 | K212155 | TheraFace LED Theragun, Inc. | OHS |
| Dec 15, 2021 | K210965 | reVive Light Therapy Essentials Led Technologies, Inc. | OHS |
| Nov 18, 2021 | K212275 | Dermalux Flex MD Aesthetic Technology, Ltd., GB | OHS |
| Jul 14, 2021 | K202390 | Aduro Light Beauty Mask Shenzhen Kaiyan Medical CO , Ltd., CN | OHS |
| Jul 14, 2021 | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therap Ningbo Hesi Electric Co., Ltd., CN | OHS |
| Jun 29, 2021 | K210954 | Synergy Yrs Group, Inc. | OHS |
| Nov 19, 2020 | K202442 | Carewear Firefly Wrinkle Reduction Carewear Corp. | OHS |
| Jun 22, 2020 | K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro) Gtg Wellness Co., Ltd., KR | OHS |
| Sep 12, 2019 | K191629 | faceLITE Ismart Marketing Svcs, Ltd., GB | OHS |
| Jun 24, 2019 | K190443 | MMSphere Galactic Beauty, LLC | OHS |
| Mar 14, 2019 | K183247 | dpl Faceware Led Technologies, Inc. | OHS |
| Jan 22, 2019 | K183671 | LG PRA.L DERMA LED MASK Lg Electronics.Inc, KR | OHS |
| Sep 14, 2018 | K180875 | POLY REJUV Medtek Skincare, LLC | OHS |
| Jul 26, 2018 | K181659 | Avologi ENEO Premier North America, Inc. | OHS |
| Jun 19, 2018 | K180856 | Neutrogena Light Therapy Aging Mask+ Johnson & Johnson Consumer, Inc. | OHS |
| Jun 7, 2018 | K172909 | ELEVARE, PERFECTIO 4 Omm Imports D/B/A Zero Gravity | OHS |
| May 15, 2018 | K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System Led Technologies, Inc. | OHS |
| Apr 3, 2018 | K180320 | dpl IIa Panel Led Technologies, Inc. | OHS |
| Jan 9, 2018 | K172662 | reVive Perioral Led Technologies, Inc. | OHS |
| Sep 1, 2017 | K171323 | BIOPHOTAS CELLUMA3 Biophotas, Inc. | OHS |
| Aug 23, 2017 | K170984 | LG BEAUTY LED MASK Lg Electronics, KR | OHS |
| Aug 7, 2017 | K171386 | dpl SpectraLite Led Technologies, Inc. | OHS |
| Aug 3, 2017 | K171390 | dpl II Panel Led Technologies, Inc. | OHS |
| Jul 12, 2017 | K163137 | NIRA Beauty Skin Laser Dermal Photonics Corporation | OHS |
| Apr 14, 2017 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 Pulsaderm, LLC | OHS |
| Mar 25, 2017 | K162784 | Silk'n HST Home Skinovations , Ltd., IL | OHS |
| Jan 13, 2017 | K162489 | RED Light Device Zhongshan Bisen Plastic Electronic Products Co., Ltd., CN | OHS |
| Jul 29, 2016 | K161849 | Bright Tanda Beauty Canada, Inc., CA | OHS |
| Feb 25, 2016 | K152332 | Perfectio LED infrared device Omm Imports Inc Dba Zero Gravity | OHS |
| Feb 24, 2016 | K151337 | Strialite Centre Light Solutions, LLC | OHS |
| Oct 23, 2015 | K151336 | LightStim Professional 2-Panel Light Led Intellectual Properties, LLC | OHS |
| Apr 9, 2015 | K150098 | LightStim Professional 2-Panel Light Led Intellectual Properties, LLC | OHS |
| Mar 31, 2015 | K141181 | NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES Led Technologies, LLC | OHS |
| Jan 15, 2015 | K140471 | PRO X OTC 5 La Lumiere, LLC | OHS |
| Nov 13, 2014 | K133896 | REJUVALITE MD Trophy Skin, Inc. | OHS |
| Aug 20, 2014 | K141308 | NUTRA LIGHT RED Nutra Luxe MD, LLC | OHS |
| Aug 6, 2014 | K133546 | STARLITE-OM, LIGHT EFFECTS, THIBIANT Ps Advanced Engineering | OHS |
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