The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Four Modifications To Ophthalas Argon/dye Laser.
| Device ID | K881494 |
| 510k Number | K881494 |
| Device Name: | FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER |
| Classification | Laser, Ophthalmic |
| Applicant | BIOPHYSIC MEDICAL, INC. 2440 ESTAND WAY Pleasant Hill, CA 94523 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson BIOPHYSIC MEDICAL, INC. 2440 ESTAND WAY Pleasant Hill, CA 94523 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-08 |
| Decision Date | 1988-08-30 |