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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 Wrinkle Reduction
510(k) Number K140471
Device Name PRO X OTC 5
Applicant
La Lumiere, LLC
12101 Cullne Blvd. Suite A
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
La Lumiere, LLC
12101 Cullne Blvd. Suite A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number878.4810
Classification Product Code
OHS  
Date Received02/25/2014
Decision Date 01/15/2015
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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