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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 K152688
Device Name LightLas Multi-Wavelength Medical Laser System
Applicant
Lightmed Corporation
# 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist
New Taipei City,  TW 23861
Applicant Contact Mollie Li
Correspondent
Lightmed Corporation
# 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist
New Taipei City,  TW 23861
Correspondent Contact Mollie Li
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/18/2015
Decision Date 06/15/2016
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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