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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K091534
Device Name LIGHTLAS MODEL 532
Applicant
Lightmed Corp.
#1-1, Lane1,Pao-An St. Sec.3
Shulin City
Taipei,  TW 238
Applicant Contact ANITA CHEN
Correspondent
Lightmed Corp.
#1-1, Lane1,Pao-An St. Sec.3
Shulin City
Taipei,  TW 238
Correspondent Contact ANITA CHEN
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/26/2009
Decision Date 09/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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