EQUINOX CO2 LASER SYSTEM

Powered Laser Surgical Instrument With Microbeam\fractional Output

ECLIPSEMED GLOBAL, INC

The following data is part of a premarket notification filed by Eclipsemed Global, Inc with the FDA for Equinox Co2 Laser System.

Pre-market Notification Details

Device IDK100487
510k NumberK100487
Device Name:EQUINOX CO2 LASER SYSTEM
ClassificationPowered Laser Surgical Instrument With Microbeam\fractional Output
Applicant ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas,  TX  75248
ContactConnie Hoy
CorrespondentConnie Hoy
ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas,  TX  75248
Product CodeONG  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-19
Decision Date2010-11-29
Summary:summary

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