The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Ophthalas Dye Ophthalmic Laser.
| Device ID | K873460 |
| 510k Number | K873460 |
| Device Name: | OPHTHALAS DYE OPHTHALMIC LASER |
| Classification | Laser, Ophthalmic |
| Applicant | BIOPHYSIC MEDICAL, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon BIOPHYSIC MEDICAL, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-28 |
| Decision Date | 1987-10-29 |