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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 10 of 15

Device	Model / Reference	Registries	Class	Status
Lletz Electrode	XF2	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE301	EUDAMEDFDA UDI	Class IIb	Active
Emerge	0500-0001	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC7B/4	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE311	EUDAMEDFDA UDI	Class IIb	Active
Microstan Monopolar Forceps	IEC-MJ21	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD9B/4	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Bipolar Forceps	ACBF-010	EUDAMEDFDA UDI	Class IIb	Active
Matrixectomy Electrode Set	H9	EUDAMEDFDA UDI	Class IIb	Active
OVAL Loop ELECTRODE	TP6B	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD10B	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	QTEE301	EUDAMEDFDA UDI	Class IIb	Active
ThermaGuide Cannula for SideLaze800, 150mm	100-7014-150	EUDAMEDFDA UDI	Class IIa	Active
Lap Trode	L4	EUDAMEDFDA UDI	Class IIb	Active
101 Electrode	T101B	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	TA9B	EUDAMEDFDA UDI	Class IIb	Active
1/8" Pin Electrode	133D	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode	XW2	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrodes	W18D	EUDAMEDFDA UDI	Class IIb	Active
Rf Assisted Tonsillotomy (rat)	TEE262	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC20B/4	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W34D	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode Assortment	W4	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Turbinate Cautery Electrode	I6/JXE	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAB1B	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	TA1B	EUDAMEDFDA UDI	Class IIb	Active
Vectus	105-3500-000	EUDAMEDFDA UDI	Class IIb	Active
Handpiece	IEC-XLP1	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	XB1B	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	QTEE303	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	XA8B	EUDAMEDFDA UDI	Class IIb	Active
135 Electrode	T135B	EUDAMEDFDA UDI	Class IIb	Active
Iec Foot-Controlled Handpiece	IEC-HP1	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	TA2B	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	QTEE308	EUDAMEDFDA UDI	Class IIb	Active
122 Electrode	T122B	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB10B	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP4B/4	EUDAMEDFDA UDI	Class IIb	Active
Pelleve S5 Generator, 220-240v	IEC5P-ST/220	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	XA1B	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	XC	EUDAMEDFDA UDI	Class IIb	Active
Bayonette Turbinate Electrode W Hp Long	IEC-I6D/L	EUDAMEDFDA UDI	Class IIb	Active
MicroInsulated Needle Handpiece	XH136	EUDAMEDFDA UDI	Class IIb	Active
Genital Lesion Electrode	W19	EUDAMEDFDA UDI	Class IIb	Active
114 Electrode	T114B	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD3B/4	EUDAMEDFDA UDI	Class IIb	Active
VARI-TIP Wire ELECTRODE	T118B	EUDAMEDFDA UDI	Class IIb	Active
PicoSure 532 Delivery System	100-7012-532	EUDAMEDFDA UDI	Class IIb	Active
Matrixectomy 2 / 2mm Electrode	H10D	EUDAMEDFDA UDI	Class IIb	Active
ThermaGuide Cannula for Cellulaze, 250mm	100-7014-250	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Cynosure B.V. NL

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Authorities

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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