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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 11 of 15

Device	Model / Reference	Registries	Class	Status
Rf Suction Coagulator	HD41	EUDAMEDFDA UDI	Class IIb	Active
Elite+	100-7018-010	EUDAMEDFDA UDI	Class IIb	Active
Dermatology Electrodes	DDERM40	EUDAMEDFDA UDI	Class IIb	Active
Broad Needle Electrode	TF1B/4	EUDAMEDFDA UDI	Class IIb	Active
134 Electrode	T134B	EUDAMEDFDA UDI	Class IIb	Active
Broad Needle Electrode	TF1B	EUDAMEDFDA UDI	Class IIb	Active
1-BUTTON Fingerswitch Handpiece	IEC-1FHPA	EUDAMEDFDA UDI	Class IIb	Active
Iec Blade Handpiece	IEC-H15	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC19B	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	XT	EUDAMEDFDA UDI	Class IIb	Active
Lap Trode	L6	EUDAMEDFDA UDI	Class IIb	Active
Mono Stan Rf Forceps	IEC-MJ11/M	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB4B/4	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB3B	EUDAMEDFDA UDI	Class IIb	Active
Rodin Microsurgery Handpiece	IEC-XRHPC	EUDAMEDFDA UDI	Class IIb	Active
104 Electrode	T104B	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode Assortment	W4D	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	QTA2B	EUDAMEDFDA UDI	Class IIb	Active
102 Electrode	T102B	EUDAMEDFDA UDI	Class IIb	Active
Micro-Larynx Loop Electrode	EE276	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP7B/4	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W30D	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	XBRB	EUDAMEDFDA UDI	Class IIb	Active
ThermaGuide Cannula for Smartlipo, 1000um fiber, 250mm	100-7007-350	EUDAMEDFDA UDI	Class IIa	Active
Needle Electrode	XA2B	EUDAMEDFDA UDI	Class IIb	Active
OVAL Loop ELECTRODE	TP5B	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAA8B	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD3B	EUDAMEDFDA UDI	Class IIb	Active
123 Electrode	T123B	EUDAMEDFDA UDI	Class IIb	Active
TONGUE BASE Electrodes	TEE605	EUDAMEDFDA UDI	Class IIb	Active
TempSure System, Surgical	100-7027-510	EUDAMEDFDA UDI	Class IIb	Active
HLTZ TONSILLOTOMY Electrode	TEE284	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD10B/4	EUDAMEDFDA UDI	Class IIb	Active
Genital Lesion Electrode	W16	EUDAMEDFDA UDI	Class IIb	Active
SUB MUCOSAL UPP Electrode	TEE229A/1	EUDAMEDFDA UDI	Class IIb	Active
117 Electrode	T117B	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE302	EUDAMEDFDA UDI	Class IIb	Active
Standard Electrode Set	S10B/4	EUDAMEDFDA UDI	Class IIb	Active
OVAL Loop ELECTRODE	TP6B/4	EUDAMEDFDA UDI	Class IIb	Active
Genital Lesion Electrode	W15	EUDAMEDFDA UDI	Class IIb	Active
Dental Electrode Set	EDS193B	EUDAMEDFDA UDI	Class IIb	Active
SUB MUCOSAL UPP Electrode	TEE731	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB1B/4	EUDAMEDFDA UDI	Class IIb	Active
Rf Assisted Tonsillotomy (rat)	EE264	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	TA8B	EUDAMEDFDA UDI	Class IIb	Active
Iec-Cosmetic Treatment Package	IEC-H135A	EUDAMEDFDA UDI	Class IIb	Active
LLETZ Loop Electrode	W2D	EUDAMEDFDA UDI	Class IIb	Active
Micro-Larynx Rf Probes Set	EE275A	EUDAMEDFDA UDI	Class IIb	Active
Ophthalmology Electrode Set	S12B	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	A3D/OS	EUDAMEDFDA UDI	Class IIb	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