POLARIS Q-SWITCH RUBY SYSTEM

Powered Laser Surgical Instrument

SANDSTONE MEDICAL TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Sandstone Medical Technologies, Llc with the FDA for Polaris Q-switch Ruby System.

Pre-market Notification Details

Device IDK121162
510k NumberK121162
Device Name:POLARIS Q-SWITCH RUBY SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood,  AL  35209
ContactMark Rohrer
CorrespondentMark Rohrer
SANDSTONE MEDICAL TECHNOLOGIES, LLC 105 CITATION COURT Homewood,  AL  35209
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-17
Decision Date2012-07-18
Summary:summary

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