The following data is part of a premarket notification filed by Laser, Inc. with the FDA for Alloy Scalpel Handpieces.
| Device ID | K914197 |
| 510k Number | K914197 |
| Device Name: | ALLOY SCALPEL HANDPIECES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER, INC. C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose LASER, INC. C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1992-04-10 |