The following data is part of a premarket notification filed by Derma-lase Co. with the FDA for Derma-lase Dla-1 Laser.
Device ID | K930975 |
510k Number | K930975 |
Device Name: | DERMA-LASE DLA-1 LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | DERMA-LASE CO. 3 MAIN ST. Hopkinton, MA 01748 |
Contact | Michael Barretti |
Correspondent | Michael 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 | 1993-02-24 |
Decision Date | 1993-08-19 |