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Cynosure, LLC

United States·US-MF-000010200

Last updated September 17, 2026

Information

Country: United States
Address: 5, Carlisle Road, Westford, United States
Website: www.cynosurelutronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Nirav Desai
EUDAMED SRN: US-MF-000010200
FDA FEI Number: 1000120578
DUNS Number: 780318028

Catalogue (726)

Page 12 of 15

Device	Model / Reference	Registries	Class	Status
Genital Lesion Electrode	XW18	EUDAMEDFDA UDI	Class IIb	Active
ThermaGuide Cannula for Smartlipo, 600u fiber, 150mm	100-7007-150	EUDAMEDFDA UDI	Class IIa	Active
Ace Tip Electrode	TRA8B	EUDAMEDFDA UDI	Class IIb	Active
Surgitron 4.0 Dual Rf/90 Iec 220-240v	IEC3A-S30-90/220	EUDAMEDFDA UDI	Class IIb	Active
121 Electrode	T121B	EUDAMEDFDA UDI	Class IIb	Active
Dcr Electrode	R7L	EUDAMEDFDA UDI	Class IIb	Active
Scalpel Electrodes	E3D	EUDAMEDFDA UDI	Class IIb	Active
Goisis Rf Elevator	GE1	EUDAMEDFDA UDI	Class IIb	Active
110 Electrode	T110B	EUDAMEDFDA UDI	Class IIb	Active
Scalpel Electrode	TE2B/4	EUDAMEDFDA UDI	Class IIb	Active
120 Electrode	T120B	EUDAMEDFDA UDI	Class IIb	Active
Foot-Controlled Hp	HP1	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP2B	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP10B	EUDAMEDFDA UDI	Class IIb	Active
126 Electrode	T126B	EUDAMEDFDA UDI	Class IIb	Active
Polyp Snare System	IEC-H301	EUDAMEDFDA UDI	Class IIb	Active
Mucotome Electrode Set	H140	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TB10B/4	EUDAMEDFDA UDI	Class IIb	Active
111 Electrode	T111B	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	QTA8B	EUDAMEDFDA UDI	Class IIb	Active
Dental Elec. Set	DDS35	EUDAMEDFDA UDI	Class IIb	Active
Micro-Larynx Rf Probes Set	IEC-EE275A	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB1B	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAA3B	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	TA8B/4	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W31D	EUDAMEDFDA UDI	Class IIb	Active
133 Electrode	T133B	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet Assortment	W35	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD8B/4	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB6B/4	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J11	EUDAMEDFDA UDI	Class IIb	Active
Genital Lesion Electrode	W17	EUDAMEDFDA UDI	Class IIb	Active
Medical Electrodes	DSEP40	EUDAMEDFDA UDI	Class IIb	Active
L180601	XD8B	EUDAMEDFDA UDI	Class IIb	Active
Iec Foot-Controlled Hp	IEC-XHP1	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	QXA8B	EUDAMEDFDA UDI	Class IIb	Active
Matrixectomy 2 / 4mm Electrode	H10E	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	QTEE305	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	XB4B	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAC7B	EUDAMEDFDA UDI	Class IIb	Active
IEC 1-Buttom Fingerswitch Handpiece	IEC-X1FHPA	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	T136B	EUDAMEDFDA UDI	Class IIb	Active
Revlite SI	661-1000	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC12B	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	TA9B/4	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TB9B/4	EUDAMEDFDA UDI	Class IIb	Active
Ace Tip Electrode	RACE7	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE317	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W32	EUDAMEDFDA UDI	Class IIb	Active
Rf Assisted Tonsillotomy (rat)	TEE263	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Cynosure B.V. NL

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FDA Recalls (1)

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