Clearance Summary
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) received FDA 510(k) clearance under submission number K253309, sponsored by Shenzhen Soga Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-05-19.
- Submission: K253309
- Applicant / Sponsor: Shenzhen Soga Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2026-05-19
Classification & Regulation
This clearance is catalogued under FDA product code NVK and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.