FDA 510(k) Application Details - K243330

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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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
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Regulation Number 878.4810

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Classification Product Code OHS
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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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