Clearance Summary
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II received FDA 510(k) clearance under submission number K980398, sponsored by Optomedic Medical Technologies , Ltd.. 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 1998-09-22.
- Submission: K980398
- Applicant / Sponsor: Optomedic Medical Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1998-09-22
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.