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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 K092460
Device Name STAR-LITE -LM, MODEL SL8809
Applicant
Ps Advanced Engineering
200 S. Garfield Ave.
Suite 318
Alhambra,  CA  91801
Applicant Contact WEN YANG
Correspondent
Ps Advanced Engineering
200 S. Garfield Ave.
Suite 318
Alhambra,  CA  91801
Correspondent Contact WEN YANG
Regulation Number878.4810
Classification Product Code
OHS  
Date Received08/11/2009
Decision Date 03/05/2010
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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