FDA.report

510(k) K241057

Device
Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Applicant
Wuhan Guangdun Technology Co.,Ltd..
510(k) number
K241057
Product code
NHN
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-24
Date received
2024-04-18
Regulation
890.5500
Classification name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Suzy Pan
Address
No111,Optical Chip Center,Optical Valley Ave. Wuhan CN 430022 430022

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
16957510600019LASPOTWuhan Guangdun Technology Co.,Ltd.2025-09-23

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