The following data is part of a premarket notification filed by Lasersight Technologies, Inc. with the FDA for Ultraedge Keratome Blade, Model 374803 - Acs.
| Device ID | K001144 |
| 510k Number | K001144 |
| Device Name: | ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS |
| Classification | Keratome, Ac-powered |
| Applicant | LASERSIGHT TECHNOLOGIES, INC. 3300 UNIVERSITY BLVD. SUITE 140 Winter Park, FL 32792 |
| Contact | Sam Mirza |
| Correspondent | Sam Mirza LASERSIGHT TECHNOLOGIES, INC. 3300 UNIVERSITY BLVD. SUITE 140 Winter Park, FL 32792 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-05-05 |