K935102 is an FDA 510(k) clearance for the SATURN LIGHT. This device is classified as a Light, Surgical, Accessories (Class II - Special Controls, product code FTA).
Submitted by Burton Medical Products Corp. (Van Nuys, US). The FDA issued a Cleared decision on June 27, 1994, 248 days after receiving the submission on October 22, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K935102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 1993 |
| Decision Date | June 27, 1994 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FTA — Light, Surgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |