PicoLazer Laser System

Powered Laser Surgical Instrument

Rohrer Aesthetics, LLC

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

Pre-market Notification Details

Device IDK192583
510k NumberK192583
Device Name:PicoLazer Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Rohrer Aesthetics, LLC 105 Citation Court Homewood,  AL  35209
ContactMark Rohrer
CorrespondentMark Rohrer
Rohrer Aesthetics, LLC 105 Citation Court Homewood,  AL  35209
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-19
Decision Date2020-01-17

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