YandR System, VoluDerm Handpiece, VoluDerm Tips

Electrosurgical, Cutting & Coagulation & Accessories

Pollogen Ltd.

The following data is part of a premarket notification filed by Pollogen Ltd. with the FDA for Yandr System, Voluderm Handpiece, Voluderm Tips.

Pre-market Notification Details

Device IDK220124
510k NumberK220124
Device Name:YandR System, VoluDerm Handpiece, VoluDerm Tips
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Pollogen Ltd. 6 Kaufman Street Tel Aviv,  IL 6801298
ContactSharon Ravid
CorrespondentKathy Maynor
Kathy Maynor 26 Rebecca Ct Homosassa,  FL  34446
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-18
Decision Date2022-02-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810096330055 K220124 000

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