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810nm Diode Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183122

by Shanghai Wonderful Opto-Electrics Tech. Co., Ltd

Identifiers

510(k) Number
K183122 FDA 510(k)
FDA Product Code
GEX 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 810nm Diode Laser System is a laser device (GEX product code) designed for soft tissue surgical procedures, including dermatological and plastic surgery applications. It emits a continuous-wave laser at a wavelength of 810 nanometers, which is absorbed by hemoglobin and melanin, enabling precise tissue ablation, coagulation, and vaporization with minimal thermal damage to surrounding areas.

This system is supplied as a reusable medical device and has been granted FDA 510(k) clearance under the Traditional review pathway, classified as Substantially Equivalent (SESE) to a predicate device. It is intended for use in controlled clinical environments, such as surgical suites or dermatology clinics, and requires proper training for operation. The device is not labeled as MRI-safe or sterile upon packaging, and its specifications do not indicate single-use constraints.

Frequently asked questions

What types of procedures is the 810nm Diode Laser System intended for?

The device is described as a laser system for soft tissue surgical procedures, specifically dermatological and plastic surgery applications. This is based on the description stating it is designed for those clinical areas, so clinicians can expect it to be used for skin and soft tissue work such as lesion removal or tissue remodeling.

Is the 810nm Diode Laser System supplied as a sterile product?

The data explicitly notes that the device is not labeled as sterile upon packaging, indicating it is delivered non‑sterile. Therefore users must follow standard aseptic protocols to sterilize or prepare the system before patient use, as the manufacturer does not provide it sterile.

Can the 810nm Diode Laser System be reused for multiple patients?

The specification states the system is supplied as a reusable medical device and does not mention any single‑use limitation. Consequently, after appropriate cleaning and maintenance according to the manufacturer’s instructions, the laser can be used for multiple procedures across different patients.

What regulatory pathway was used for the 810nm Diode Laser System’s clearance?

The device received FDA 510(k) clearance under the Traditional review pathway, classified as Substantially Equivalent (SESE) to a predicate device. This information comes directly from the authorization and decision description fields, confirming the regulatory route without implying any other status.

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: Diode Dental Laser (980nm/810nm)-Products-Shanghai Wonderful Opto ..., Products_list-Shanghai Wonderful Opto-Electrics Tech.Co.,LTD, 810nm Diode Dental Laser (3W) - Shanghai Wonderful Opto-Electrics Tech ..., 810nm Diode Laser System 510(k) K183122 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd
FDA Applicant
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

Sources (1)

  • FDA 510(k) K183122 24 fields · synced Sep 19, 2026