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FDA 510(k) Application Details - K213041
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K213041
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Glan Electronics Co., Ltd.
A4 Building, Huafa Industrial Zone, Fuyuan 1st Road, Xinhe
Community, Fuyong Town, Bao'an Dist
Shenzhen CN
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Contact
Lisa Pan
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2021
Decision Date
11/18/2021
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
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