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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K102134
Device Name MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
Applicant
United Integrated Services Co., Ltd.
Paochiao Rd.
8f, # 4, Aly. 1, Ln. 235
Hsintien City, Taipei Hsien,  TW 23144
Applicant Contact DAVID O CHANG
Correspondent
United Integrated Services Co., Ltd.
Paochiao Rd.
8f, # 4, Aly. 1, Ln. 235
Hsintien City, Taipei Hsien,  TW 23144
Correspondent Contact DAVID O CHANG
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/29/2010
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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