The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Model 4000 Md-yag Laser For Malignant.
| Device ID | K842412 |
| 510k Number | K842412 |
| Device Name: | MODEL 4000 MD-YAG LASER FOR MALIGNANT |
| Classification | Laser, Ophthalmic |
| Applicant | COOPER LASERSONICS, INC. 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 | 1984-06-19 |
| Decision Date | 1984-06-26 |