The following data is part of a premarket notification filed by Derma-lase Co. with the FDA for Derma-lase Ruby Laser - Model Dlr-1.
| Device ID | K913256 |
| 510k Number | K913256 |
| Device Name: | DERMA-LASE RUBY LASER - MODEL DLR-1 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DERMA-LASE CO. WARD MEMORIAL BUILDING 303 EAST CHICAGO AVENUE Chicago, IL 60611 |
| Contact | Jerome M Garden |
| Correspondent | Jerome M Garden DERMA-LASE CO. WARD MEMORIAL BUILDING 303 EAST CHICAGO AVENUE Chicago, IL 60611 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-16 |
| Decision Date | 1992-01-22 |