The following data is part of a premarket notification filed by Derma-lase Co. with the FDA for Dlr-1 Derma-lase Ruby Laser/dlr-1/derma-lase Syst.
| Device ID | K924647 |
| 510k Number | K924647 |
| Device Name: | DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DERMA-LASE CO. 3 MAIN ST. Hopkinton, MA 01748 |
| Contact | Michael L Barretti |
| Correspondent | Michael L Barretti DERMA-LASE CO. 3 MAIN ST. Hopkinton, MA 01748 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-14 |
| Decision Date | 1993-06-04 |