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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 4 of 15

Device	Model / Reference	Registries	Class	Status
LUX1540 Handpiece, Starlux	1520C-1540	FDA UDI	Class II	Active
Max G Handpiece	2520A-G046R	FDA UDI	Class II	Active
Snare Cable	H7B	FDA UDI	Class II	Active
Ace-Tip Bipolar Forceps	ACBF-015	FDA UDI	Class II	Active
30mm Portrait Handpiece	100-7027-130	FDA UDI	Class II	Active
Roto-Pro Rotosonic	ERP101	FDA UDI	Class I	Active
Max R Handpiece	2520B-R026R	FDA UDI	Class II	Active
Smartlipo Fiber w/ RFID, 1000um Fiber, 10 pack	807-5001-620	FDA UDI	Class II	Active
Large Sapphire Optic	3520C-0002R	FDA UDI	Class II	Active
Pelleve S5	IEC5P-ST/110	FDA UDI	Class II	Active
Suction Tonsillectomy Probe	IEC-H83/SP	FDA UDI	Class II	Active
EMPIRE microIncision Needle Electrodes	TEE308	FDA UDI	Class II	Active
Medlite C6	659-0020-1	FDA UDI	Class II	Active
Luxy Hp, Starlux 500	5520-Y026	FDA UDI	Class II	Active
SculpSure, Laser Assembly, Brazil	100-7026-020	FDA UDI	Class II	Active
Surgitron 4.0 Dual Rf/120 Iec 220v	IEC3A-S30/220	FDA UDI	Class II	Active
Max G Handpiece	2520A-G046	FDA UDI	Class II	Active
Pelleve Quick-Connect Cable	P2CBD	FDA UDI	Class II	Active
Vectus Diode Handpiece	3520A-0001R	FDA UDI	Class II	Active
Snare Cable	IEC-H7B	FDA UDI	Class II	Active
ASSY, Probe, Single, TempSure Vitalia	100-7037-001	FDA UDI	Class II	Active
Refusrbished, Handpiece, 532, Pico	R100-7012-076	FDA UDI	Class II	Active
Neutral Pad	IEC-NPD-S	FDA UDI	Class II	Active
PicoSure 1064 nm Handpiece	100-7012-079	FDA UDI	Class II	Active
1541 handpiece	2520C-1540R	FDA UDI	Class II	Active
Large Sapphire Optic	3520C-0002	FDA UDI	Class II	Active
20mm GlideSafe HP (3) and Cable	P220HPD	FDA UDI	Class II	Active
Refusrbished, Handpiece, 1064, Pico	R100-7012-079	FDA UDI	Class II	Active
EMPIRE microIncision Needle Electrodes	TEE314	FDA UDI	Class II	Active
Ace-Tip Bipolar Forceps	ACBF-013	FDA UDI	Class II	Active
ASSY, Face Accessory Kit, TempSure	100-7027-065	FDA UDI	Class II	Active
Assy, Focus Array, 3pk, W/Box, Pico300	100-7051-068	FDA UDI	Class II	Active
MaxG HP, Artisan	8520A-G046	FDA UDI	Class II	Active
Non-Slip Grip Tip Pilers	EGT188	FDA UDI	Class I	Active
Corneal Shield	H77A	FDA UDI	Class I	Active
Suction Coag. Tube 6", 3/32" Caliber	H45	FDA UDI	Class II	Active
PelleFirm 30MM HP, 3-pack	P330PFHPU	FDA UDI	Class II	Active
Iec Neutral Pad	IEC-NPD	FDA UDI	Class II	Active
Corneal Shield	H75A	FDA UDI	Class I	Active
Hypo-Cal	EHC136	FDA UDI	Class II	Active
Assy, 1540 Handpiece, Icon	2520D-1540	FDA UDI	Class II	Active
Surgitron 4.0 Dual Rf/90	IEC3A-S30-90/110	FDA UDI	Class II	Active
Quick Connect Cable	IEC-SP020	FDA UDI	Class II	Active
585nm Revlite SI Dye Handpiece, Gold	100-7017-062	FDA UDI	Class II	Active
SculpSure Applicator, Refurbished	R100-7026-100	FDA UDI	Class II	Active
Dual Frequency Footswitch and Cable	DF-FSC#	FDA UDI	Class II	Active
Perf-Grid	EPG107	FDA UDI	Class I	Active
Hypo-Cal	EHC136B	FDA UDI	Class II	Active
Vectus Diode Handpiece	3520A-0001	FDA UDI	Class II	Active
ASSY, Head, Massage, Cellulite, 60mm, TempSure	ASY-12746	FDA UDI	Class II	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