FDA Product Code
FDA Product Code ONE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | 2025-04-18 | Traditional | PDF ↗ |
| K171055 | Philips BlueControl | Philips Electronics Nederland B.V. | 2017-07-06 | Traditional | PDF ↗ |
| K103415 | TANDA MAX | Pharos Life Corporation | 2011-01-03 | Traditional | PDF ↗ |
| K100628 | PLASMALUXLS | Daavlin Distributing Co. | 2010-11-24 | Traditional | PDF ↗ |
| K091467 | BABY QUASAR | Silver Bay, LLC | 2010-09-17 | Traditional | PDF ↗ |
| K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Verilux | 2010-09-03 | Traditional | PDF ↗ |
| K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Led Intellectual Properties, LLC | 2010-02-04 | Traditional | PDF ↗ |
Product code ONE · Class II · General, Plastic Surgery. Data: openFDA.