Cleared Traditional

SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) (K253309) - FDA 510(k) Clearance

Also marketed or referenced as:
SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253309 · Shenzhen Soga Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
232d
Days
Class 2
Risk

K253309 is an FDA 510(k) clearance for the SOGA Lasers therapy system family of Aurora handpiece (Aurora-S). Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by Shenzhen Soga Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 19, 2026 after a review of 232 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4810 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Soga Technology Co., Ltd. devices

Submission Details

510(k) Number K253309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date May 19, 2026
Days to Decision 232 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 127d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVK Laser, Dental, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NVK Laser, Dental, Soft Tissue

All 16
Devices cleared under the same product code (NVK) and FDA review panel - the closest regulatory comparables to K253309.
Gemini NOVA 810+980 Soft Tissue Laser
K260765 · Azena Medical, LLC · Mar 2026
MateLaser Medical Diode Laser Systems (ML-DLS-30)
K250731 · Matelaser, Inc. · Oct 2025
Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
K243764 · Wuhan Pioon Technology Co., Ltd. · May 2025
Medical Diode Laser Systems
K230047 · Gigaalaser Company , Ltd. · Mar 2024
Dawn Diode Laser System
K232885 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Feb 2024
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
K232222 · Medency S.R.L. · Nov 2023