Clearance Summary
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI received FDA 510(k) clearance under submission number K854470, sponsored by Minnesota Laser Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1986-02-07.
- Submission: K854470
- Applicant / Sponsor: Minnesota Laser Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1986-02-07
Classification & Regulation
This clearance is catalogued under FDA product code HHR and 21 CFR 884.4550, within the Obstetrics/Gynecology review panel as a Class II device.