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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 K171443
Device Name Etherea MX
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  
Subsequent Product Codes
ILY   ONF   PDZ  
Date Received05/16/2017
Decision Date 04/20/2018
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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