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 Number | 886.4390
|
Classification Product Code |
|
Date Received | 12/30/2015 |
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
|
|
|