K000728 is an FDA 510(k) clearance for the MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on March 21, 2000, 15 days after receiving the submission on March 6, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K000728 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2000 |
| Decision Date | March 21, 2000 |
| Days to Decision | 15 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 |