The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Interconn. Of Ophthalas & Nanolas Laser System.
| Device ID | K883719 |
| 510k Number | K883719 |
| Device Name: | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM |
| Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| 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 | LQJ |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-31 |
| Decision Date | 1988-10-18 |