Clearance Summary
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT received FDA 510(k) clearance under submission number K134036, sponsored by Loktal Medical Electronics Ind. Com. Ltda- Epp. 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 2015-10-08.
- Submission: K134036
- Applicant / Sponsor: Loktal Medical Electronics Ind. Com. Ltda- Epp
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2015-10-08
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.