The following data is part of a premarket notification filed by Medical Energy, Inc. with the FDA for Sl-100 Nd:yag Laser For Gynecology Use.
| Device ID | K871512 |
| 510k Number | K871512 |
| Device Name: | SL-100 ND:YAG LASER FOR GYNECOLOGY USE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDICAL ENERGY, INC. 2413 EXECUTIVE PLAZA Pensacola, FL 32504 |
| Contact | David P Lewing |
| Correspondent | David P Lewing MEDICAL ENERGY, INC. 2413 EXECUTIVE PLAZA Pensacola, FL 32504 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1988-07-08 |