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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K252325
Device Name Hair Growth Laser Cap
Applicant
Cosmo Far East Technology Limited
3f Bldg. 11, Section B Of Xue Zi Wei Industrial Park
Shajing St. Bo'An St.
Shenzhen,  CN
Applicant Contact Bob An
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Central Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/25/2025
Decision Date 10/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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