Clearance Summary
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL received FDA 510(k) clearance under submission number K870505, sponsored by Trimedyne, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1987-08-07.
- Submission: K870505
- Applicant / Sponsor: Trimedyne, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4500
- Decision date: 1987-08-07
Classification & Regulation
This clearance is catalogued under FDA product code LLO and 21 CFR 874.4500, within the Ear, Nose, Throat review panel as a Class II device.