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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
Applicant
Lutronic Corporation
219, Sowon-Ro, Deogyang-Gu
Goyang-Si,  KR 410-220
Applicant Contact Jhung Won Vojir
Correspondent
Lutronic, Inc.
6 Neshaminy Interplex, Suite 100
Trevose,  PA  19053
Correspondent Contact Jhung Won Vojir
Regulation Number886.4390
Classification Product Code
HQF  
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
Predetermined Change
Control Plan Authorized		 No
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