The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Lasag Microruptor 2 Nd:yag Ophth. Laser System.
| Device ID | K885164 |
| 510k Number | K885164 |
| Device Name: | LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Susan Gamble |
| Correspondent | Susan Gamble CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-13 |
| Decision Date | 1989-01-10 |