FDA 510(k) Application Details - K122725

Device Classification Name	Heat Source For Bleaching Teeth   More FDA Info for this Device
510(K) Number	K122725
Device Name	Heat Source For Bleaching Teeth
Applicant	SYNERON BEAUTY 1835 MARKET ST., 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE M HOGAN Other 510(k) Applications for this Contact
Regulation Number	872.6475   More FDA Info for this Regulation Number
Classification Product Code	EEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2012
Decision Date	11/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review