Clearance Summary
FOX 810, FOX 980 received FDA 510(k) clearance under submission number K220531, sponsored by A.R.C Laser GmbH. 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 2022-09-01.
- Submission: K220531
- Applicant / Sponsor: A.R.C Laser GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-09-01
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.