Clearance Summary
Syneron CO2RE System received FDA 510(k) clearance under submission number K181523, sponsored by Syneron-Candela Corp. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2018-07-11.
- Submission: K181523
- Applicant / Sponsor: Syneron-Candela Corp
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2018-07-11
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.