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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2018 | Quasar Bio-Tech, Inc. Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. Terminated |
OHS | K130225 |
| Jun 29, 2018 | Quasar Bio-Tech, Inc. Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. Terminated |
OHS | K130225 |
| Jun 29, 2018 | Quasar Bio-Tech, Inc. Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. Terminated |
OHS | K130225 |
| Apr 30, 2009 | Sybaritic, Inc Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Operation: Operation with Intermittent/continuous load, Visible and Invisible LED Ra Terminated |
OHS | None listed |
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