FDA 510(k) Application Details - K121435

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K121435
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 YOKNEAM ILLIT 20692 IL Other 510(k) Applications for this Company
Contact	AMIR WALDMAN 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	05/14/2012
Decision Date	02/22/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review