The following data is part of a premarket notification filed by California Laboratories, Inc. with the FDA for Iris Nd:yag Opthalmic Laser.
| Device ID | K883270 |
| 510k Number | K883270 |
| Device Name: | IRIS ND:YAG OPTHALMIC LASER |
| Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Applicant | CALIFORNIA LABORATORIES, INC. 2270-M CAMINO VIDA ROBLE Carlsbad, CA 92009 -4894 |
| Contact | Kenneth R Michael |
| Correspondent | Kenneth R Michael CALIFORNIA LABORATORIES, INC. 2270-M CAMINO VIDA ROBLE Carlsbad, CA 92009 -4894 |
| Product Code | LQJ |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-03 |
| Decision Date | 1988-10-13 |