The following data is part of a premarket notification filed by Sunrise Technologies, Inc. with the FDA for Model Dlase 300 Nd:yag Laser System: Intraoral.
| Device ID | K900539 |
| 510k Number | K900539 |
| Device Name: | MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SUNRISE TECHNOLOGIES, INC. C/O CHARLES L. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose SUNRISE TECHNOLOGIES, INC. 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 | 1990-02-05 |
| Decision Date | 1990-05-03 |