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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 6 of 15

Device	Model / Reference	Registries	Class	Status
Yabe Dcr Disposable Electrode	YABE/D	FDA UDI	Class II	Active
Bipolar Cable	IEC-BC	FDA UDI	Class II	Active
Small Sapphire Optic	3520A-0003R	FDA UDI	Class II	Active
SideLaze 3D Fiber w/RFID, 1000um, 10 pack	807-5001-616	FDA UDI	Class II	Active
Ellman Cots	ECOTS	FDA UDI	Class I	Active
650nm Dye Handpiece, Red	100-7017-061	FDA UDI	Class II	Active
Cellulaze Handpiece, 2 Pack	100-7014-015	FDA UDI	Class II	Active
ASSY, 60MM Body Accessory Kit, TempSure	ASY-12944	FDA UDI	Class II	Active
LUX1540 Handpiece, REMANUFACTURED	1520C-1540R	FDA UDI	Class II	Active
Assy, Focus Array, Pico300	100-7051-057	FDA UDI	Class II	Active
ASSY, Final TempSure, Surgical, Refurb	R100-7027-510	FDA UDI	Class II	Active
F.f.p.f. Emc	EMC100	FDA UDI	Class II	Active
Speculum Package	H58	FDA UDI	Class I	Active
Pv Glidesafe Hp	P275HPD	FDA UDI	Class II	Active
Bipolar Forceps	J20	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J18	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J1	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J7D	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J17	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J7	EUDAMEDFDA UDI	Class IIb	Active
Diamond Electrode	TC4B	EUDAMEDFDA UDI	Class IIb	Active
3-Button Fingerswitch Hp	IEC-3FHPB/D	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J10	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAEE287	EUDAMEDFDA UDI	Class IIb	Active
Ball Electrode	D8D	EUDAMEDFDA UDI	Class IIb	Active
Lap Trode	L3	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAB2B	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	TA3B/4	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP3B	EUDAMEDFDA UDI	Class IIb	Active
Lletz Bayonet	W34	EUDAMEDFDA UDI	Class IIb	Active
Needle Electrode	XA9B	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	XPRB	EUDAMEDFDA UDI	Class IIb	Active
Ace-Tip Electrode	TNAA9B	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC20B	EUDAMEDFDA UDI	Class IIb	Active
Microinsulated Needle	H137	EUDAMEDFDA UDI	Class IIb	Active
108 Electrode	T108B	EUDAMEDFDA UDI	Class IIb	Active
Polyp Snare System	H301	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J13	EUDAMEDFDA UDI	Class IIb	Active
Oval Loop Electrode	TP3B/4	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB5B	EUDAMEDFDA UDI	Class IIb	Active
PicoSure 1064 Delivery System	100-7012-164	EUDAMEDFDA UDI	Class IIb	Active
Cynergy	100-7002-180	EUDAMEDFDA UDI	Class IIb	Active
EMPIRE microIncision Needle Electrodes	TEE307	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J2	EUDAMEDFDA UDI	Class IIb	Active
MicroInsualted Needle Handpiece	IEC-XH136	EUDAMEDFDA UDI	Class IIb	Active
Bipolar Forceps	J5	EUDAMEDFDA UDI	Class IIb	Active
Triangle Loop Electrode	TC11B	EUDAMEDFDA UDI	Class IIb	Active
Insulated Needle	D7	EUDAMEDFDA UDI	Class IIb	Active
Diamond Loop Electrode	TC3B	EUDAMEDFDA UDI	Class IIb	Active
Round Loop Electrode	TB5B/4	EUDAMEDFDA UDI	Class IIb	Active

Related Companies

Authorised Representatives

Cynosure B.V. NL

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Notified Bodies

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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