Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)— 510(k) K241057

Name: FDA 510(k) clearance K241057
Creator: U.S. Food and Drug Administration
Published: 2025-01-24

Substantially Equivalent

Wuhan Guangdun Technology Co.,Ltd..

FDA 510(k) clearance K241057 for Enhanced Handheld Pain Relief Laser Instrument (GD-P-E), Substantially Equivalent on 2025-01-24. Applicant: Wuhan Guangdun Technology Co.,Ltd... Device class: 2.

Clearance details

Applicant: Wuhan Guangdun Technology Co.,Ltd..
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2024-04-18
Decision date: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, CN

Download summary PDF View on FDA.gov ↗

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