Clearance Summary
DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST received FDA 510(k) clearance under submission number K924647, sponsored by Derma-Lase Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-06-04.
- Submission: K924647
- Applicant / Sponsor: Derma-Lase Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1993-06-04
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.