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Cynosure, LLC

United States·US-MF-000010200

Last updated September 17, 2026

Information

Page 15 of 15

Device	Model / Reference	Registries	Class	Status
ENDO-CERVICAL Electrode	F2D	EUDAMEDFDA UDI	Class IIb	Active
Elite MPX	100-7009-010	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	XAB/4	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE325	EUDAMEDFDA UDI	Class IIb	Active
Rodin Rf Microsurgery Se	RODIN1	EUDAMEDFDA UDI	Class IIb	Active
Broad Needle Electrode	XF1B	EUDAMEDFDA UDI	Class IIb	Active
Assorted Loop Electrode	XBB/4	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J7U	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode	W3	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W31	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP4B	EUDAMEDFDA UDI	Class IIb	Active
Rf Angled Suction Coagulator	HD42	EUDAMEDFDA UDI	Class IIb	Active
Mono Stan Rf Forceps	MJ11	EUDAMEDFDA UDI	Class IIb	Active
Ophthalmic Micro-Dissection	A10	EUDAMEDFDA UDI	Class IIb	Active
Broad Needle Electrode	F1D	EUDAMEDFDA UDI	Class IIb	Active
Standard Electro Set	S10B	EUDAMEDFDA UDI	Class IIb	Active
Ace Tip Electrode	TRBBB	EUDAMEDFDA UDI	Class IIb	Active
Mono Stan Rf Forceps	IEC-MJ11	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode	W2	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE316	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	C3D	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	XA3B	EUDAMEDFDA UDI	Class IIb	Active
Affirm 10mm Tip	100-7004-910	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	XB	EUDAMEDFDA UDI	Class IIb	Active
JAVATE Electrode	R6	EUDAMEDFDA UDI	Class IIb	Active
Rhinophyma Electrode Set	EE234	EUDAMEDFDA UDI	Class IIb	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 9, 2014	Z-0169-2015	—	terminated	If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock