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FDA 510(k) Application Details - K203271
Device Classification Name
Over-The-Counter Powered Light Based Laser For Acne
More FDA Info for this Device
510(K) Number
K203271
Device Name
Over-The-Counter Powered Light Based Laser For Acne
Applicant
Shenzhen Kaiyan Medical CO LTD
40A Fuxin Road, Fuyong Subdistrict, BaoAn District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Alain Dijkstra
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
11/06/2020
Decision Date
07/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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