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FDA 510(k) Application Details - K191754
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K191754
Device Name
Laser, Comb, Hair
Applicant
Kunshan Bella Optical technology Co., Ltd.
Plant 2, Kunshan Development Zone,
No. 218 Cheng Hu Road
Kunshan 215300 CN
Other 510(k) Applications for this Company
Contact
Wu Xuefeng
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
07/01/2019
Decision Date
11/22/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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