The following data is part of a premarket notification filed by Sunrise Technologies, Inc. with the FDA for Laser Fiberoptic Delivery System.
| Device ID | K915352 |
| 510k Number | K915352 |
| Device Name: | LASER FIBEROPTIC DELIVERY 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 | 1991-11-26 |
| Decision Date | 1991-12-17 |