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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K220041
Device Name HandPICO
Applicant
Vydence Medical Industria E Comercio Ltda
Rua Aldo Germano Klein, 359 Cep: 13.573-470 - Caixa
Postal 772
Ceat - Sao Carlos/Sp Sao Paulo,  BR 13.573-470
Applicant Contact Kathy Maynor
Correspondent
Kathy Maynor
26 Rebecca Ct.
Homosassa,  FL  34446
Correspondent Contact Kathy Maynor
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/05/2022
Decision Date 05/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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