K260690

LumiGlam Laser System (SHE-LSP601-3)

510(k) number
K260690
Device name
LumiGlam Laser System (SHE-LSP601-3)
Applicant
Beijing Sano Laser S&T Development Co.,Ltd CN
Product code
GEX — Powered Laser Surgical Instrument
Decision date
2026-06-04
Date received
2026-03-03
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260690
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.