The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Zyoptix Xp Microkeratome.
| Device ID | K040204 |
| 510k Number | K040204 |
| Device Name: | ZYOPTIX XP MICROKERATOME |
| Classification | Keratome, Ac-powered |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Debra L.b. Ketchum |
| Correspondent | Debra L.b. Ketchum BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-03-22 |
| Summary: | summary |