Clearance Summary
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. received FDA 510(k) clearance under submission number K871220, sponsored by Cooper Lasersonics, 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 1987-07-16.
- Submission: K871220
- Applicant / Sponsor: Cooper Lasersonics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1987-07-16
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.