Address:Goeschwitzer Strasse 51-52,JENA Thuringia,DE
Device Description : The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted i The MEL 80 Excimer Laser System is indicated for use in primary Laser Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of - myopia of less than or equal to -7.0 D with or without refractive astigmatism of less than or equal to -3.0 D, with a Maximum MRSE of -7.0 D- naturally occurring hyperopia of less than or equal to +5.0 D with or without refractive astigmatism of greater than +0.5 D and less than or equal to +3.0 D, with a maximum MRSE of +5.0 D in patients who are 21 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by Change in sphere and cylinder of 0.5 D.
Device Class : 3
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : No
Device Description : This database entry covers UDI for SW Versions 4.1 and higher: (01)0404947107002 This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Version 4.1.1; (01)04049471070026(10)420 -> Version 4.2; (01)04049471070026(10)421 -> Version 4.2.1; (01)04049471070026(10)423 -> Version 4.2.3; (01)04049471070026(10)424 -> Version 4.2.4, (01)04049471070026(10)425 -> Version 4.2.5, (01)04049471070026(10)426 -> Version 4.2.6
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : Yes
Device Description : This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplac This database entry covers UDI for SW Versions 2.0 and higher (Glaucoma Workplace): (01)04049471070101(10)310 -> Version 3.1, (01)04049471070101(10)311 -> Version 3.1.1, (01)04049471070101(10)350 -> Version 3.5
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : Yes
Device Description : This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118 This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : Yes
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SL 115 Classic Slit Lamp is a AC-powered slit lamp biomicroscope intended fo The SL 115 Classic Slit Lamp is a AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment. The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : No
Device Description : The SL 120 Slit Lamp is an AC-powered slit lamp biomicroscopes intended for use The SL 120 Slit Lamp is an AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment.The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : No
Device Description : The SL 130 Slit Lamp is an AC-powered slit lamp biomicroscopes intended for use The SL 130 Slit Lamp is an AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment.The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : No
Device Description : he AT 030 is an appliance that serves to measure intraocular pressure, according he AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : Yes
Device Description : The VISULAS Trion Laser System is intended for use in single-spot laser photocoa The VISULAS Trion Laser System is intended for use in single-spot laser photocoagulation of ocular tissues for the treatment of diseases of the eye, such as:* Photocoagulation of the retina* Trabeculoplasty for treatment of glaucoma* Iridotomy for treatment of glaucoma.The VISULAS Trion Laser System with the VITE option is intended for use in multispot retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:* Proliferative and nonproliferative diabetic retinopathy* Macular edema* Branch and central retinal vein occlusion* Lattice degeneration* Retinal tears and detachments* Choroidal neovascularization associated with wet age-related macular degeneration.
Device Class : 2
Duns Number: 314594680
Premarket Exempt : No
Prescription Use : No