HandPICO

Powered Laser Surgical Instrument

Vydence Medical Industria E Comercio Ltda

The following data is part of a premarket notification filed by Vydence Medical Industria E Comercio Ltda with the FDA for Handpico.

Pre-market Notification Details

Device IDK220041
510k NumberK220041
Device Name:HandPICO
ClassificationPowered Laser Surgical Instrument
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
ContactKathy Maynor
CorrespondentKathy Maynor
Kathy Maynor 26 Rebecca Ct Homosassa,  FL  34446
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-05
Decision Date2022-05-05

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