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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 K133546
Device Name STARLITE-OM, LIGHT EFFECTS, THIBIANT
Applicant
Ps Advanced Engineering
200 S Garfield Ave. Suite 103
Alhambra,  CA  91801
Applicant Contact CD FEAK
Correspondent
Ps Advanced Engineering
200 S Garfield Ave. Suite 103
Alhambra,  CA  91801
Correspondent Contact CD FEAK
Regulation Number878.4810
Classification Product Code
OHS  
Date Received11/19/2013
Decision Date 08/06/2014
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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