K241699

SUPER VELOCE

510(k) number
K241699
Device name
SUPER VELOCE
Applicant
Ilooda Co,., Ltd. KR
Product code
GEX — Powered Laser Surgical Instrument
Decision date
2024-08-13
Date received
2024-06-13
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: K241699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.