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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 K172791
Device Name Lumilisse IPL Hair Remover
Applicant
Conair Corporation
One Cummings Pt. Rd.
Stamford,  CT  06902
Applicant Contact Mike Cantrell
Correspondent
Smith Associates
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received09/15/2017
Decision Date 01/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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