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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K220124
Device Name YandR System, VoluDerm Handpiece, VoluDerm Tips
Applicant
Pollogen Ltd.
6 Kaufman Street
Tel Aviv,  IL 6801298
Applicant Contact Sharon Ravid
Correspondent
Kathy Maynor
26 Rebecca Ct
Homosassa,  FL  34446
Correspondent Contact Kathy Maynor
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/18/2022
Decision Date 02/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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