The following data is part of a premarket notification filed by Coherent Medical Division with the FDA for Model 900k Photocoagulator.
| Device ID | K801336 |
| 510k Number | K801336 |
| Device Name: | MODEL 900K PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | COHERENT MEDICAL DIVISION 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-04 |
| Decision Date | 1980-07-28 |