Clearance Summary
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) received FDA 510(k) clearance under submission number K862150, sponsored by Directed Energy, 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 1986-09-04.
- Submission: K862150
- Applicant / Sponsor: Directed Energy, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4500
- Decision date: 1986-09-04
Classification & Regulation
This clearance is catalogued under FDA product code EWG and 21 CFR 874.4500, within the Ear, Nose, Throat review panel as a Class II device.