The following data is part of a premarket notification filed by American Medical Optics with the FDA for Amer. Medical Optics Argon/krypton Lase.
| Device ID | K842250 |
| 510k Number | K842250 |
| Device Name: | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE |
| Classification | Laser, Ophthalmic |
| Applicant | AMERICAN MEDICAL OPTICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-08-15 |