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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 K201854
Device Name CAPOGEN Laser Cap
Applicant
Nature Incredible Inc
3422 Old Capitol Trail #569
Wilmington,  DE  19808
Applicant Contact John Lee
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center
Guimiao Road
Shenzhen,  CN 518000
Correspondent Contact Gamma Zhang
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/06/2020
Decision Date 09/01/2020
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
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