Identifiers
- 510(k) Number
- K230047 FDA 510(k)
- FDA Product Code
- NVK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medical Diode Laser Systems are class 2 laser devices intended for soft‑tissue applications, including dental procedures and general or plastic surgery. They employ diode technology to deliver precise laser energy for cutting, coagulation, and tissue remodeling.
The system is cleared under FDA 510(k) (traditional) with decision date 2024‑03‑04 (K230047) and carries product code NVK. It is supplied by Gigaalaser Company Ltd. in Wuhan, China, and is regulated as a medical laser device; no specific sterility, single‑use, or MRI safety information is provided in the data.
Frequently asked questions
What is the Medical Diode Laser System intended for?
The Medical Diode Laser System is a class 2 laser device intended for soft-tissue applications, including dental procedures and general or plastic surgery, using diode technology to deliver precise laser energy for cutting, coagulation, and tissue remodeling.
How is the Medical Diode Laser System supplied and by whom?
The system is supplied by Gigaalaser Company Ltd. from their facility in Wuhan, China, located at the Wuhan Hi-Tech Medical Device Industrial Park, as indicated in the manufacturer’s address details.
What regulatory pathway was used for the Medical Diode Laser System?
The device was cleared through the FDA 510(k) traditional pathway, with decision K230047 granted on March 4, 2024, and is classified as a class 2 medical device under product code NVK.
Does the device data specify whether the Medical Diode Laser System is sterile or single-use?
No specific information about sterility, single-use status, or reuse is provided in the device data; therefore, these characteristics cannot be confirmed from the available information.
What product code and regulation number are associated with the Medical Diode Laser System?
The device is assigned product code NVK and regulation number 878.4810, as recorded in the FDA’s database for this 510(k) clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - GigaaMedical is a leading global manufacturer and OEM of medical ..., Gigaalaser Company Ltd, Products - GigaaMedical is a leading global manufacturer and OEM of ..., Dentistry Laser Manufacturer | Gigaalaser, Gigaalaser - LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230047 | Class II | Active |
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Manufacturer
- Manufacturer
- Gigaalaser Company Ltd.
- FDA Applicant
- Gigaalaser Company , Ltd.
Sources (1)
- FDA 510(k) K230047 24 fields · synced Sep 19, 2026