Clearance Summary
OW100S received FDA 510(k) clearance under submission number K233937, sponsored by Softwave/Trt, 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 2024-07-09.
- Submission: K233937
- Applicant / Sponsor: Softwave/Trt, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4685
- Decision date: 2024-07-09
Classification & Regulation
This clearance is catalogued under FDA product code PZL and 21 CFR 878.4685, within the General, Plastic Surgery review panel as a Class II device.