Light Based Over The Counter Wrinkle Reduction
General, Plastic Surgery · 21 CFR 878.4810
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
Recent MDR events
100 adverse event reports on file
- BEAUTY SET SKINLEDJul 20, 2026InjuryPhilipsMW5190850
- SHARK CRYOGLOWJul 10, 2026InjurySharkninja Operating Llc3013738756-2026-00043
- SKIN REJUVENATE FACE MASKJul 9, 2026InjuryShenzhen Perfect Idea Technology LimitedMW5190551
- SHARK CRYOGLOWJul 7, 2026InjurySharkninja Operating Llc3013738756-2026-00041
- SHARK CRYOGLOWJul 6, 2026InjurySharkninja Operating Llc3013738756-2026-00045
- SHARK CRYOGLOWJul 3, 2026InjurySharkninja Operating Llc3013738756-2026-00042
- SHARK CRYOGLOWJul 2, 2026InjurySharkninja Operating Llc3013738756-2026-00037
- SHARK CRYOGLOWJun 29, 2026InjurySharkninja Operating Llc3013738756-2026-00039
- SHARK CRYOGLOWJun 29, 2026InjurySharkninja Operating Llc3013738756-2026-00040
- SHARK CRYOGLOWJun 18, 2026Injury3013738756-2026-00038
Event type breakdown
Recalls
4 recall events for this product code
- Sybaritic, IncTerminatedApr 30, 2009
Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/conti
Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.
Z-1308-2009 · View FDA record ↗ - Quasar Bio-Tech, Inc.TerminatedUnknown
Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Z-2973-2018 · View FDA record ↗ - Quasar Bio-Tech, Inc.TerminatedUnknown
Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Z-2974-2018 · View FDA record ↗ - Quasar Bio-Tech, Inc.TerminatedUnknown
Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
Z-2975-2018 · View FDA record ↗
Registered firms
270 firms currently registered for this product code
Gymmax Technology Shenzhen Co., Ltd
Shenzhen City Guangdong, CN
Kaertech Electronics Philippines Inc
Binan Laguna, PH
Therabody, Inc.
Los Angeles, CA, US
Shenzhen Sungpo Hi-tech Electronic Co., Ltd
Shenzhen Guangdong, CN
Light Tree Ventures Europe B.v.
'S-Gravenhage Zuid-Holland, NL
Merchsource Llc
Irvine, CA, US
Longcheer Meiko Electronics Vietnam Company Limited
Hanoi Ha Noi, VN
Dermatech Innovations Llc
Bal Harbour, FL, US
Led Intellectual Properties Llc
Irvine, CA, US
Avazzia, Inc.
DALLAS, TX, US
Heat In A Click Llc
Dania, FL, US
Xiamen Solex High-tech Industries Co.,ltd
Xiamen Fujian, CN
Shenzhen Ulike Smart Electronics Co.,ltd
Shenzhen Guangdong, CN
Shenzhen Zowee Smart Manufacturing Co., Ltd.
Shenzhen Guangdong, CN
Duplex International Trading Limited
Hong Kong, HK
Opatra
Las Vegas, NV, US
Led Technologies, Inc.
Largo, FL, US
Omm Imports, Inc. D/b/a Zero Gravity
Miami Beach, FL, US
Weccan (vietnam) Technology Company Limited
Dau Giay Dong Nai, VN
Shenzhen Jianchao Intelligent Technology Co., Ltd.
Shenzhen Guangdong, CN
Shenzhen Nuon Medical Equipment Co., Ltd.
ShenZhen Guangdong, CN
Ningbo Yimei Nikko-seiki Manufacture Co., Ltd
Yuyao City Zhejiang, CN
Silk'n Beauty Ltd.
Rotterdam Zuid-Holland, NL
510(k) clearances
161 clearances for this product code
- Shenzhen Chuangtong Yigou Technology Co., Ltd.Aug 7, 2026
K261601 · LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
- Duplex International Trading LimitedAug 4, 2026
K261496 · LED Light Therapy Masks (PE748, PE749, PE756)
- Shenzhen Qianyu Technology Co., Ltd.Aug 4, 2026
K261851 · LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
- Led Intellectual Properties, LLCJul 31, 2026
K261482 · LightStim for Wrinkles (1984); LightStim for Acne (2038)
- iSMART Developments, Ltd.Jul 24, 2026
K260598 · 5 Wavelength LED Facemask (TN2508)
- Dongguan Miqiang Technology Co., Ltd.Jul 15, 2026
K261407 · XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
- Termosalud S.L.Jul 1, 2026
K261473 · Chromix
- Guangdong Newdermo Biotech Co., Ltd.Jun 29, 2026
K261052 · LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)