The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Nanolas Nd:yag Ophthalmic Laser.
| Device ID | K881459 |
| 510k Number | K881459 |
| Device Name: | NANOLAS ND:YAG OPHTHALMIC LASER |
| Classification | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| 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 | LOI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-06 |
| Decision Date | 1988-04-13 |