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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 13 of 15

Device	Model / Reference	Registries	Class	Status
Needle Electrode	TA3/OS	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode Set	XD	EUDAMEDFDA UDI	Class IIb	Active
Micro-Larynx Needle Electrode	EE277	EUDAMEDFDA UDI	Class IIb	Active
Vari-Tip Wire Electrode	X118B	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC6B	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB2B/4	EUDAMEDFDA UDI	Class IIb	Active
ENDOCERVICAL BAYONET Electrode	W33D	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAEE284	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	XCRB	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Bipolar Forceps	ACBF-026	EUDAMEDFDA UDI	Class IIb	Active
LLETZ Loop Electrode	W1D	EUDAMEDFDA UDI	Class IIb	Active
Foot-Controlled Hp	XHP1	EUDAMEDFDA UDI	Class IIb	Active
Bayonette Turbinate Electrode With Hp	IEC-I6D	EUDAMEDFDA UDI	Class IIb	Active
3-Button Fingerswitch Handpiece	IEC-3FHPB	EUDAMEDFDA UDI	Class IIb	Active
Insulated Needle	D6A	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC14B	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB9B	EUDAMEDFDA UDI	Class IIb	Active
130 Electrode	T130B	EUDAMEDFDA UDI	Class IIb	Active
1-Button Fingerswitch Handpiece	XKO1	EUDAMEDFDA UDI	Class IIb	Active
Medlite C6	659-0030-1	EUDAMEDFDA UDI	Class IIb	Active
105 Electrode	T105B	EUDAMEDFDA UDI	Class IIb	Active
Affirm 14mm Tip	100-7004-814	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	XTRB	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W32D	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC8B/4	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	XD9B	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC18B	EUDAMEDFDA UDI	Class IIb	Active
Scalpel Electrode Bendable	TE3B	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode	XW3	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB4B	EUDAMEDFDA UDI	Class IIb	Active
Lletz Electrode	W1	EUDAMEDFDA UDI	Class IIb	Active
3-BUTTON FingerSwitch BLADE Handpiece	IEC-X3FHPB	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	XBRB/4	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	XA	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W30	EUDAMEDFDA UDI	Class IIb	Active
Apogee+	100-7018-290	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J21	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	XPFB	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC9B	EUDAMEDFDA UDI	Class IIb	Active
Conization Electrode	G1	EUDAMEDFDA UDI	Class IIb	Active
LLETZ Electrodes Assortment	W35D	EUDAMEDFDA UDI	Class IIb	Active
109 Electrode	T109B	EUDAMEDFDA UDI	Class IIb	Active
PicoSure Pro	100-7051-010	EUDAMEDFDA UDI	Class IIb	Active
Scalpel Electrodes	E4D	EUDAMEDFDA UDI	Class IIb	Active
Ophthalmic Micro-Dissection	TA10/C1	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC7B	EUDAMEDFDA UDI	Class IIb	Active
Scalpel Electrode	TE1B	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP1B	EUDAMEDFDA UDI	Class IIb	Active
LLETZ Loop Electrode	W3D	EUDAMEDFDA UDI	Class IIb	Active
108H Electrode	T108HB	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