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FDA 510(k) Application Details - K243330
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K243330
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
LYMA Life Ltd.
2nd Floor Edison House
223-231 Old Marylebone Road
London NW1 5QT GB
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Contact
Lucy Goff
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/24/2024
Decision Date
02/21/2025
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
FDA Source Information for K243330
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