The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope(r) Ktp/532 And Ktp/yag Surgical Laser.
| Device ID | K911830 |
| 510k Number | K911830 |
| Device Name: | LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERSCOPE C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose LASERSCOPE 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 | 1991-04-24 |
| Decision Date | 1991-08-14 |