The following data is part of a premarket notification filed by Laserscope with the FDA for Ktp/532 Surgical Laser System W/ktp/yag Module.
| Device ID | K895945 |
| 510k Number | K895945 |
| Device Name: | KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Richard P Rudy |
| Correspondent | Richard P Rudy LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1990-04-09 |