Clearance Summary
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL received FDA 510(k) clearance under submission number K872254, sponsored by Surgical Laser 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 1987-12-14.
- Submission: K872254
- Applicant / Sponsor: Surgical Laser Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1987-12-14
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.