The following data is part of a premarket notification filed by Surgical Laser Products, Inc. with the FDA for Surgi Light Nd:yag Laser System Model 904030.
| Device ID | K915768 |
| 510k Number | K915768 |
| Device Name: | SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER PRODUCTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | Toby Johnston |
| Correspondent | Toby Johnston SURGICAL LASER PRODUCTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-02-11 |