FDA 510(k) clearance · back to tracker

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

Shenzhen Soga Technology Co., Ltd. cleared K253309 on 2026-05-19, decision: substantially equivalent

K-number

K253309

Sponsor

Shenzhen Soga Technology Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-19

Product code

NVK

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4810

Official FDA record

Open K253309on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.