The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Microlase 8 0 0 (ophthalmic Laser).
| Device ID | K890086 |
| 510k Number | K890086 |
| Device Name: | MICROLASE 8 0 0 (OPHTHALMIC LASER) |
| Classification | Laser, Ophthalmic |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Van Arsdale |
| Correspondent | Van Arsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-10 |
| Decision Date | 1989-03-15 |