Clearance Summary
RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY received FDA 510(k) clearance under submission number K051671, sponsored by Radiancy (Israel) , 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 2005-09-02.
- Submission: K051671
- Applicant / Sponsor: Radiancy (Israel) , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2005-09-02
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.