510(k) K251464

Device
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
Applicant
Jeisys Medical Incorporated
510(k) number
K251464
Product code
GEX
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-03
Date received
2025-05-13
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jeongwook Lee
Address
307 Daeryung Techno Town 8th Gamasan-Ro 96, Geumcheon-Gu Seoul KR 08501 08501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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