Clearance Summary
PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T received FDA 510(k) clearance under submission number K854471, sponsored by Minnesota Laser Corp.. 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 1986-02-13.
- Submission: K854471
- Applicant / Sponsor: Minnesota Laser Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4500
- Decision date: 1986-02-13
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.