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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 K153769
Device Name R:GEN Laser System
Lutronic Corporation
219, Sowon-ro, Deogyang-gu
Goyang-si,  KR 410-220
Applicant Contact Jhung Won Vojir
Lutronic, Inc.
6 Neshaminy Interplex, Suite 100
Trevose,  PA  19053
Correspondent Contact Jhung Won Vojir
Regulation Number886.4390
Classification Product Code
Date Received12/30/2015
Decision Date 10/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No