The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Laser Indirect Ophthalmoscope (lio).
| Device ID | K885196 |
| 510k Number | K885196 |
| Device Name: | LASER INDIRECT OPHTHALMOSCOPE (LIO) |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Contact | Alan Voss |
| Correspondent | Alan Voss COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-16 |
| Decision Date | 1989-01-11 |