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 |
|---|---|---|---|
| Feb 5, 2014 | K132613 | SONILASE LIGHT THERAPY DEVICE Biorenew Labs, LLC | OHS |
| Jan 15, 2014 | K133473 | ILUMINAGE SKIN SMOOTHING LASER Cynosure, Inc. | OHS |
| Dec 19, 2013 | K124064 | YOUNG AGAIN Espansione Marketing S.P.A, IT | OHS |
| Jul 11, 2013 | K130225 | QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE Silverbay, LLC, D/B/A Quasar Bio-Tech | OHS |
| Nov 6, 2012 | K120560 | TRINITY WRINKLE REMOVER Carol Cole Company | OHS |
| Aug 14, 2012 | K112362 | C100 WRINKLE REDUCTION DEVICE Silver Bay, LLC | OHS |
| Jul 5, 2012 | K111454 | ILUMINAGE DIODE LASER Cynosure, Inc. | OHS |
| Jun 4, 2012 | K120775 | LIGHT FOR WRINKLES Led Intellectual Properties, LLC | OHS |
| Aug 19, 2011 | K110301 | SILK'N FX Home Skinovations , Ltd., IL | OHS |
| Aug 3, 2011 | K110735 | TANDA MAX OTC SYSTEM Pharos Life Corporation | OHS |
| Nov 9, 2010 | K101382 | DPL NUVE Led Technologies, LLC | OHS |
| Jul 1, 2010 | K101190 | LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC Led Intellectual Properties, LLC | OHS |
| Mar 5, 2010 | K092460 | STAR-LITE -LM, MODEL SL8809 Ps Advanced Engineering | OHS |
| Mar 3, 2008 | K072459 | OMNILUX NEW-U Photo Therapeutics, Inc. | OHS |
| Feb 15, 2008 | K062991 | GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE Light Bioscience, LLC | OHS |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.