Manufacturer

Alcon

United StatesLegal entities : Alcon Laboratories, Inc.

Markets : Belgium · Denmark · Finland · France · Germany · Italy · Poland · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 98 · PMA : 43 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 136 · Spain 64 · Italy 22 · Finland 9 · Sweden 7 · Poland 6 · Belgium 4 · Denmark 2 · Germany 1

EU representative : Alcon Laboratories Belgium (Belgium)

Website regulatory-1.operations@Alcon.com

18 categories, 44 models including 44 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Phaco-vitrectomy instruments - consumables	Z1212020785	Bulk Non-Sterile Small Parts Kit3 refs Constellation22 refs Fiber Optic Probes3 refs Intrepid6 refs Intrepid 0.3 Polymer I/A Tips3 refs 6 others Intrepid 0.3mm Polymer I/A Hand Piece3 refs Legion LenSx3 refs Non-Valved Entry Systems3 refs Small Parts Kit (Bulk Non-Sterile)3 refs TurboSonics , ABS3 refs	I, IIa, IIb MDR	EUDAMED record Report an error
Therapeutic and surgical ophtholmological treatments instruments - consumables	Z12120285	Constellation2 refs GRIESHABER Laser Probes3 refs ModifEYE™3 refs UltraFlow™2 refs 1 other WaveLight	IIa, IIb MDR	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - other	Z12120199	INNOVEYES™ NGENUITY 1.5 Verion3 refs	IIa MDR	EUDAMED record Report an error
Phaco-vitrectomy instruments - hardware accessories	Z1212020780	Active Sentry3 refs Legion UltraFlow	IIa, IIb MDR	EUDAMED record Report an error
Therapeutic and surgical ophtholmological treatments instruments - other	Z12120299	LenSx VOYAGER DSLT WaveLight	IIb MDR	EUDAMED record Report an error
Operative microscopes	Z12011101	LuxOR3 refs NGENUITY 1.4	I MDR	EUDAMED record Report an error
Ophthalmological instrument stands	Z12129001	Legion Wavelight	I MDR	EUDAMED record Report an error
Phaco-emulsifiers	Z1212020701	Legion93/42 UNITY	IIb MDR, 93/42	EUDAMED record Report an error
Phaco-vitrectomy systems	Z1212020702	Constellation2 refs93/42 UNITY	IIb MDR, 93/42	EUDAMED record Report an error
Therapeutic and surgical ophtholmological treatments instruments - hardware accessories	Z12120280	Adaptation PUREPOINT	IIb MDR	EUDAMED record Report an error
Computerised corneal topographs	Z12120123	ALLEGRO TOPOLYZER	IIa MDR	EUDAMED record Report an error
Laser photocoagulators	Z12120202	PurePoint2 refs	IIb MDR	EUDAMED record Report an error
Microkeratome lasers	Z1212020501	WaveLight FS200	IIb MDR	EUDAMED record Report an error
Operating tables	Z12011202	WaveLight	I MDR	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - hardware accessories	Z12120180	ORA SYSTEM2 refs	I MDR	EUDAMED record Report an error
Ophthalmic microdiathermy coagulators	Z1212020602	Ophthalmic Diathermy Probes DSP2 refs	IIb MDR	EUDAMED record Report an error
Therapeutic and surgical ophtholmological treatments instruments - software accessories	Z12120282	WAVENET	IIb MDR	EUDAMED record Report an error
Various ophtalmology instruments - software accessories	Z12129082	Alcon Online Toric IOL Calculator	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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