Dermal Cooling System

Powered Laser Surgical Instrument

R2 Technologies, Inc.

The following data is part of a premarket notification filed by R2 Technologies, Inc. with the FDA for Dermal Cooling System.

Pre-market Notification Details

Device IDK213294
510k NumberK213294
Device Name:Dermal Cooling System
ClassificationPowered Laser Surgical Instrument
Applicant R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon,  CA  94583
ContactRagan Reppond
CorrespondentTarhan Kayihan
R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon,  CA  94583
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-10-01
Decision Date2022-11-10

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