K253309

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)

510(k) number: K253309
Device name: SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
Applicant: Shenzhen Soga Technology Co., Ltd. CN
Product code: NVK — Laser, Dental, Soft Tissue
Decision date: 2026-05-19
Date received: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

Also available from FDA: K253309.pdf

Official FDA record: K253309

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