Clearance Summary
Looper (Model: ZX-579S) received FDA 510(k) clearance under submission number K202055, sponsored by Heat IN A Click, LLC. 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 2021-04-16.
- Submission: K202055
- Applicant / Sponsor: Heat IN A Click, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2021-04-16
Classification & Regulation
This clearance is catalogued under FDA product code OLP and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.