The following data is part of a premarket notification filed by Sunrise Technologies, Inc. with the FDA for Model Slase 210 Holmium Laser System.
| Device ID | K920248 |
| 510k Number | K920248 |
| Device Name: | MODEL SLASE 210 HOLMIUM LASER SYSTEM |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | SUNRISE TECHNOLOGIES, INC. 47257 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose SUNRISE TECHNOLOGIES, INC. 47257 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-21 |
| Decision Date | 1992-07-21 |