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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 14 of 15

Device	Model / Reference	Registries	Class	Status
Round Loop	B1D	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP8B/4	EUDAMEDFDA UDI	Class IIb	Active
Rf Assisted Tonsillotomy (rat)	TEE261	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP7B	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	A8D	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAD3B	EUDAMEDFDA UDI	Class IIb	Active
SUB MUCOSAL UPP Electrode	TEE229A	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE305	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNATB3B	EUDAMEDFDA UDI	Class IIb	Active
Ophthalmic Micro-Dissection	TA10/C2	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	XPRB/4	EUDAMEDFDA UDI	Class IIb	Active
Micro-Larynx Ball Electrode	EE278A	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J19	EUDAMEDFDA UDI	Class IIb	Active
FINE WIRE Needle Electrode	A2D	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAB5B	EUDAMEDFDA UDI	Class IIb	Active
Grafting Electrode	EDE112	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC3B/4	EUDAMEDFDA UDI	Class IIb	Active
Dcr Electrode	R7S	EUDAMEDFDA UDI	Class IIb	Active
Cynergy PDL	100-7005-180	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	QTEE327	EUDAMEDFDA UDI	Class IIb	Active
Insulated Needle	D6C	EUDAMEDFDA UDI	Class IIb	Active
Insulated Needle Set	QD7	EUDAMEDFDA UDI	Class IIb	Active
Surgitron 4.0 Dual Rf 120	IEC3A-S30	EUDAMEDFDA UDI	Class IIb	Active
Dr. Sherman Electrodes	EJS104	EUDAMEDFDA UDI	Class IIb	Active
124 Electrode	T124B	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE327	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J4	EUDAMEDFDA UDI	Class IIb	Active
WEDGE RESECTION Electrode	EE255	EUDAMEDFDA UDI	Class IIb	Active
Myringotomy Electrodes	TEE230	EUDAMEDFDA UDI	Class IIb	Active
PicoSure	100-7012-010	EUDAMEDFDA UDI	Class IIb	Active
Revlite	661-0020-1	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrodes	QW18D	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	TD9B	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	XD3B	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAEE286	EUDAMEDFDA UDI	Class IIb	Active
Standard Electrode Set	QS10B	EUDAMEDFDA UDI	Class IIb	Active
Rodin Microsurgery Handpiece	XRHP	EUDAMEDFDA UDI	Class IIb	Active
128 Electrode	T128B	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J3	EUDAMEDFDA UDI	Class IIb	Active
Insulated Needle	XD6A	EUDAMEDFDA UDI	Class IIb	Active
Punctal Occlusion Electrode 1/16" Shaft	TNAEE330	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP9B/4	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J8	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB6B	EUDAMEDFDA UDI	Class IIb	Active
Genital Lesion Electrode	W18	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAEE305	EUDAMEDFDA UDI	Class IIb	Active
Pelleve S5	IEC5P-ST/110-USA	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC17B	EUDAMEDFDA UDI	Class IIb	Active
Empire Microincision Needle Electrodes	QTEE302	EUDAMEDFDA UDI	Class IIb	Active
Scalpel Electrode	TE2B	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