Ziemer Ophthalmic Systems AG

Web: http://ziemer-ophthalmics.com
Address: 11 Allmendstrasse, Port CH-2562, Switzerland
Phone: +41-(32)-332 7050 | Fax: +41-(32)-332 7071 | Map/Directions >>

Profile: Ziemer Ophthalmic Systems AG specializes in providing diagnostic and surgical tools to ophthalmologists and optometrists. Our product line includes Galilei™, Amadeus'®, Femto LDV™, swiss blade, Pascal dynamic contour tonometer and Maxwell™ optical wavefront aberrometer. Our Galilei™ dual Scheimpflug analyzer is a high precision optical system for corneal topography and three dimensional analysis of the anterior eye segment. Our analyzer provides accurate curvature data and precise elevation data. It incorporates several important diagnostic modalities. Our analyzer has high resolution Scheimpflug images, corneal and lens topography, 3D anterior chamber analysis and crystalline lens thickness. Our Amadeus'® is a multi-purpose platform for Lasik, epi-Lasik and anterior & posterior Lamellar Keratoplasty. Our Femto LDV is a mobile femtosecond surgical laser, which is ideal for corneal surgery. It has smooth surface of stromal bed, smooth edges for optimal flap closure and thin flaps of even thickness.

FDA Registration Number: 3004858034
US Agent: Kevin Walls / Regulatory Insight, Inc.
Phone: +1-(720)-962-5412  Fax: +1-(720)-962-5413  E-Mail:

12 Products/Services (Click for related suppliers)  
• AC-Powered Keratome (FDA Code: HNO / 886.4370)
A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
• Anterior Segment Analysis Device (FDA Code: MXK / 886.1850)
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
• Applanation Tonometers
• Disposable Surgical Blades
• Disposable Surgical Knives
• Dyanamic Contour Tonometer
• Hand Held Laser Delivery System
• Manual Tonometer (FDA Code: HKY / 886.1930)
A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
• Ophthalmic Aberrometer (FDA Code: NCF / 886.1760)
An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.
• Ophthalmic Knife (FDA Code: HNN / 886.4350)
A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.
• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810)
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.
• Surgical Knife (FDA Code: EMF / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

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