FDA 510(k) Application Details - K240456

Device Classification Name Laser, Comb, Hair

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510(K) Number K240456
Device Name Laser, Comb, Hair
Applicant PLM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
1499 NW 79th Ave
Miami, FL 33126 US
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Contact Ira Nusbaum
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 02/15/2024
Decision Date 05/22/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240456


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