The following data is part of a premarket notification filed by Sunrise Technologies, Inc. with the FDA for Model Dlaser 1000 Nd;yag Laser System.
| Device ID | K914568 |
| 510k Number | K914568 |
| Device Name: | MODEL DLASER 1000 ND;YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-15 |
| Decision Date | 1991-11-07 |