The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Lds - Laser Delivery System.
| Device ID | K862568 |
| 510k Number | K862568 |
| Device Name: | LDS - LASER DELIVERY SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Contact | Alan L Voss |
| Correspondent | Alan L Voss COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-07 |
| Decision Date | 1986-10-07 |