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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K253754
Device Name Philips Lumea IPL
Applicant
Philips Consumer Lifestyle B.V.
Tussendiepen 4
Drachten,  NL 9206 AD
Applicant Contact Martijn Halbesma
Correspondent
Philips Personal Health, Philips North America, LLC
1600 Summer St.
5th Floor
Stamford,  CT  06905
Correspondent Contact Shaylee Masilunas
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
GEX  
Date Received11/25/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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