Clearance Summary
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN received FDA 510(k) clearance under submission number K863221, sponsored by Laserscope. 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 1987-03-02.
- Submission: K863221
- Applicant / Sponsor: Laserscope
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1987-03-02
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.