FDA 510(k) Application Details - K223862

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K223862
Device Name	Laser, Comb, Hair
Applicant	Won Tech Co., Ltd. 64 Techno 8-Ro, Yuseong-gu Daejeon 34028 KR Other 510(k) Applications for this Company
Contact	Hyun Sik Yoon 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	12/23/2022
Decision Date	04/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review