FDA 510(k) Application Details - K183329

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K183329
Device Name	Laser, Comb, Hair
Applicant	OMM Imports, Inc. D/B/A Zero Gravity 1945 S Ocean Dr Apt 509 Hallandale Beach Blvd Hallandale, FL 33009 US Other 510(k) Applications for this Company
Contact	Moti Shenfarber Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	OAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2018
Decision Date	01/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review