FDA 510(k) Applications for Medical Device Product Code "ONE"
(Powered Light Based Non-Laser Surgical Instrument)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K100628 | DAAVLIN DISTRIBUTING CO. | PLASMALUXLS | 11/24/2010 |
| K250224 | iSMART Developments LTD | handLITE (TN19S) | 04/18/2025 |
| K092800 | LED INTELLECTUAL PROPERTIES, LLC | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | 02/04/2010 |
| K103415 | PHAROS LIFE CORPORATION | TANDA MAX | 01/03/2011 |
| K171055 | Philips Electronics Nederland B.V. | Philips BlueControl | 07/06/2017 |
| K091467 | SILVER BAY, LLC | BABY QUASAR | 09/17/2010 |
| K091125 | VERILUX | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | 09/03/2010 |
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