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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 K142172
Device Name LIGHTMED TRUSCAN 577
Applicant
LIGHTMED CORP.
NO.1-1, LANE1,PAO-AN ST. SEC.3
SHULIN DIST
NEW TAIPEI CITY,  TW 23861
Applicant Contact ANGEL HSIEH
Correspondent
LIGHTMED CORP.
NO.1-1, LANE1,PAO-AN ST. SEC.3
SHULIN DIST
NEW TAIPEI CITY,  TW 23861
Correspondent Contact ANGEL HSIEH
Regulation Number886.4390
Classification Product Code
HQF  
Date Received08/07/2014
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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