Clearance Summary
MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA received FDA 510(k) clearance under submission number K861046, sponsored by Sharplan Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1986-05-02.
- Submission: K861046
- Applicant / Sponsor: Sharplan Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1986-05-02
Classification & Regulation
This clearance is catalogued under FDA product code LNK and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.