Cleared Traditional

K230047 - Medical Diode Laser Systems (FDA 510(k) Clearance)

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

K230047 · Gigaalaser Company , Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
423d
Days
Class 2
Risk

K230047 is an FDA 510(k) clearance for the Medical Diode Laser Systems. Classified as Laser, Dental, Soft Tissue (product code NVK), Class II - Special Controls.

Submitted by Gigaalaser Company , Ltd. (Wuhan, CN). The FDA issued a Cleared decision on March 4, 2024 after a review of 423 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Gigaalaser Company , Ltd. devices

Submission Details

510(k) Number K230047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2023
Decision Date March 04, 2024
Days to Decision 423 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
296d slower than avg
Panel avg: 127d · This submission: 423d
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 15
Devices cleared under the same product code (NVK) and FDA review panel - the closest regulatory comparables to K230047.
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
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
Solea
K221761 · Convergent Dental, Inc. · Sep 2022