SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) +1 more— 510(k) K253309

Name: FDA 510(k) clearance K253309
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Substantially Equivalent

Shenzhen Soga Technology Co., Ltd.

FDA 510(k) clearance K253309 for SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) +1 more, Substantially Equivalent on 2026-05-19. Applicant: Shenzhen Soga Technology Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code NVK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-09-29
Decision date: 2026-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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