FUSION SYSTEM

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

ECLIPSEMED GLOBAL, INC

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

Pre-market Notification Details

Device IDK093465
510k NumberK093465
Device Name:FUSION SYSTEM
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas,  TX  75248
ContactIgor Gradov
CorrespondentIgor Gradov
ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas,  TX  75248
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-06
Decision Date2010-01-05
Summary:summary

Trademark Results [FUSION SYSTEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FUSION SYSTEM
FUSION SYSTEM
90478027 not registered Live/Pending
Biomea Fusion, Inc.
2021-01-20
FUSION SYSTEM
FUSION SYSTEM
76114274 not registered Dead/Abandoned
NEXICOR, LLC
2000-08-22

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