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 |