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Light Based Over The Counter Wrinkle Reduction
FDA product code OHS · Class 2 · General, Plastic Surgery
398
Registered devices
107
Adverse events
4
Recalls
163
510(k) clearances
Devices with this code
reVive® — LED TECHNOLOGIES INCJIANCHAO SMART — Shenzhen Jianchao Intelligent Technology Co., LtdDreame — Shenzhen Rainbow Technology Co.,LtdSilk'n — Silkn Beauty Ltd.Juvenis — Omm Imports Inc.ACE-TEC — Guangdong Ace-Tec Co.,LtdSMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches — I-SMART DEVELOPMENTS LIMITEDN/A — Guangdong Newdermo Biotech Co.,Ltd.AURA — Guangdong Newdermo Biotech Co.,Ltd.reVive Light Therapy® — LED TECHNOLOGIES INCdpl® — LED TECHNOLOGIES INCPMD — Shenzhen Fittop Health Technology Co., Ltd.NuFACE — NufaceDp DERMACEUTICALS L.E.D.+ FACE — I-SMART DEVELOPMENTS LIMITEDSharper Image — Merchsource, LLCPriori UnveiLED — I-SMART DEVELOPMENTS LIMITEDKakusan — SZ KKS Silicone&Electronic Co.,LtdPMD — Dongguan Hunter Electronic Technology Co., Ltd.Lip Revive — LED TECHNOLOGIES INCNIRA Pro (Gen 3,Champagne) — Nira Innovations IncorporatedLED Light Therapy Mask — Shenzhen Rainbow Technology Co.,LtdELEVARE — zhongshan Bisen plastic electronic products CO,LTDShark CryoGlow — SharkNinja Operating LLCMe — Tanda Beauty Canada, Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-29 | Quasar Bio-Tech, Inc. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| 2018-06-29 | Quasar Bio-Tech, Inc. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| 2018-06-29 | Quasar Bio-Tech, Inc. | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals. |
| 2008-06-18 | Sybaritic, Inc | Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported. |
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