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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 K243453
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, A Subsidiary of Philips
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 Received11/07/2024
Decision Date 02/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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