Clearance Summary
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS received FDA 510(k) clearance under submission number K050950, sponsored by Active Optical Systems, Ltd./Efraim Bidas. 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 2005-04-29.
- Submission: K050950
- Applicant / Sponsor: Active Optical Systems, Ltd./Efraim Bidas
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2005-04-29
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.