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 |