FDA 510(k) Application Details - K124042

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K124042
Device Name	Over-The-Counter Powered Light Based Laser For Acne
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	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2012
Decision Date	04/02/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review