PINXEL-RF System

Electrosurgical, Cutting & Coagulation & Accessories

Rohrer Aesthetics, LLC

The following data is part of a premarket notification filed by Rohrer Aesthetics, Llc with the FDA for Pinxel-rf System.

Pre-market Notification Details

Device IDK180654
510k NumberK180654
Device Name:PINXEL-RF System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Rohrer Aesthetics, LLC 105 Citation Court Homewood,  AL  35209
ContactMark Rohrer
CorrespondentMark Rohrer
Rohrer Aesthetics, LLC 105 Citation Court Homewood,  AL  35209
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-13
Decision Date2018-07-13
Summary:summary

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