K030891 is an FDA 510(k) clearance for the SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Surgistar, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 17, 2003, 88 days after receiving the submission on March 21, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K030891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2003 |
| Decision Date | June 17, 2003 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HNO — Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |