Clearance Summary
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE received FDA 510(k) clearance under submission number K864946, sponsored by Bio Quantum Technologies, Inc.. 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 1988-01-28.
- Submission: K864946
- Applicant / Sponsor: Bio Quantum Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1988-01-28
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.