Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K251457

Diode laser therapy device (VADER)

510(k) number
K251457
Device name
Diode laser therapy device (VADER)
Applicant
Beijing Superlaser Technology Co., Ltd. CN
Product code
GEX — Powered Laser Surgical Instrument
Decision date
2025-09-03
Date received
2025-05-12
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K251457.pdf

Official FDA record: K251457
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.