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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
No. 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist
New Taipei City,  TW 23861
Applicant Contact Mollie Li
Correspondent
LIGHTMED CORPORATION
No. 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
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