Clearance Summary
TANDA PEARL, ULTRAWYTE, PEARL received FDA 510(k) clearance under submission number K122725, sponsored by Syneron Beauty. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2012-11-27.
- Submission: K122725
- Applicant / Sponsor: Syneron Beauty
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6475
- Decision date: 2012-11-27
Classification & Regulation
This clearance is catalogued under FDA product code EEG and 21 CFR 872.6475, within the Dental review panel as a Class I device.