← Back to catalogue

980nm Diode Laser Therapy Device

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191349

by Shanghai Apolo Medical Technology Co., Ltd

Identifiers

510(k) Number
K191349 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 980nm Diode Laser Therapy Device is a laser therapy device designed for low-level laser therapy (LLLT), delivering non-thermal photobiomodulation to promote tissue repair and reduce inflammation. It emits a continuous-wave laser at a wavelength of 980 nanometers, targeting cellular mechanisms to enhance healing processes in soft tissues and skin.

This device is intended for single-use applications in clinical settings, including general and plastic surgery environments. Supplied sterile and packaged for professional use, it adheres to FDA 510(k) clearance under the General, Plastic Surgery advisory committee classification. Compliance with MDD (Medical Device Directive) ensures its regulatory standing in European markets, with no MRI safety restrictions specified.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shanghai Apolo Medical Technology Co., Ltd
FDA Applicant
Shanghai Apolo Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K191349 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026