Clearance Summary
ULTRA BEAUTY received FDA 510(k) clearance under submission number K112351, sponsored by Johari Digital Healthcare , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-03-30.
- Submission: K112351
- Applicant / Sponsor: Johari Digital Healthcare , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2012-03-30
Classification & Regulation
This clearance is catalogued under FDA product code NFO and 21 CFR 882.5890, within the Neurology review panel as a Class II device.