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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K241057
Device Name Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Applicant
Wuhan Guangdun Technology Co.,Ltd.
No111,Optical Chip Center,Optical Valley Avenue
Wuhan,  CN 430022
Applicant Contact Suzy Pan
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.5500
Classification Product Code
NHN  
Date Received04/18/2024
Decision Date 01/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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