SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) +1 more— 510(k) K253309
Substantially EquivalentShenzhen 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.
Summary
Shenzhen Soga Technology's record covers two SOGA Lasers therapy system entries: an Aurora handpiece (Aurora-S) and a dental diode laser (ILaser III Pro). The product code is NVK, dental soft tissue lasers.
Class II, 21 CFR 878.4810. The Dental review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Soga filed from Shenzhen, China. The decision came 232 calendar days after receipt (September 29, 2025 to May 19, 2026).
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
- Product code NVK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code NVK
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