The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Nd:yag Laser 4000/6000/8000 Endometrial Ablation.
| Device ID | K862456 |
| 510k Number | K862456 |
| Device Name: | ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles Rose |
| Correspondent | Charles Rose COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-27 |
| Decision Date | 1986-08-12 |