The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Lq1106 Ophthalmic Yag Laser.
| Device ID | K882772 |
| 510k Number | K882772 |
| Device Name: | LQ1106 OPHTHALMIC YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-06 |
| Decision Date | 1988-08-26 |