Panels › General, Plastic Surgery › Product code ONE · Class 2
Powered Light Based Non-Laser Surgical Instrument
Regulation 878.4810
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ONE
| Company | 510(k)s | Recalls |
|---|---|---|
| Daavlin Distributing Co. | 1 | 0 |
| iSMART Developments, Ltd. | 1 | 0 |
| Led Intellectual Properties, LLC | 1 | 0 |
| Pharos Life Corporation | 1 | 0 |
| Philips Electronics Nederland B.V. | 1 | 0 |
| Silver Bay, LLC | 1 | 0 |
| Verilux | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 18, 2025 | K250224 | handLITE (TN19S) iSMART Developments, Ltd., GB | ONE |
| Jul 6, 2017 | K171055 | Philips BlueControl Philips Electronics Nederland B.V., NL | ONE |
| Jan 3, 2011 | K103415 | TANDA MAX Pharos Life Corporation, CA | ONE |
| Nov 24, 2010 | K100628 | PLASMALUXLS Daavlin Distributing Co. | ONE |
| Sep 17, 2010 | K091467 | BABY QUASAR Silver Bay, LLC | ONE |
| Sep 3, 2010 | K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 Verilux | ONE |
| Feb 4, 2010 | K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL Led Intellectual Properties, LLC | ONE |
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