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 ID | K093465 |
| 510k Number | K093465 |
| Device Name: | FUSION SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas, TX 75248 |
| Contact | Igor Gradov |
| Correspondent | Igor Gradov ECLIPSEMED GLOBAL, INC 16850 DALLAS PARKWAY Dallas, TX 75248 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2010-01-05 |
| Summary: | summary |
Trademark Results [FUSION SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FUSION SYSTEM 90478027 not registered Live/Pending |
Biomea Fusion, Inc. 2021-01-20 |
 FUSION SYSTEM 76114274 not registered Dead/Abandoned |
NEXICOR, LLC 2000-08-22 |
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