Clearance Summary
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION received FDA 510(k) clearance under submission number K862456, 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 1986-08-12.
- Submission: K862456
- Applicant / Sponsor: Cooper Lasersonics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1986-08-12
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.