K080962 is an FDA 510(k) clearance for the LITE WAND II. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Thompson Surgical Instruments, Inc. (Traverse City, US). The FDA issued a Cleared decision on June 25, 2008, 82 days after receiving the submission on April 4, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K080962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2008 |
| Decision Date | June 25, 2008 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FST - Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |