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Sign in to claim this brandSIS AG, Surgical Instrument Systems
US
Last updated May 24, 2026
What SIS AG, Surgical Instrument Systems makes
SIS AG produces software applications for corneal topography and anterior segment analysis in ophthalmology, including systems for optical low coherence reflectometry (OLCR) biometry. Their portfolio also includes single-use keratome blades and non-medicated ophthalmic surgical procedure kits, as well as standalone devices like the Galilei G6 for refractive surgery planning. These tools are designed for diagnostic imaging and precision surgical preparation in eye care settings.
The company’s devices are regulated under FDA classifications, with some falling under Class I and others under Class II. Products are listed via the FDA’s 510(k) and UDI programs, ensuring compliance with US medical device regulations. SIS AG operates from the United States, where these devices are authorised for commercial distribution.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does SIS AG manufacture?
SIS AG specializes in ophthalmic devices and software applications. Their portfolio includes corneal topography systems, anterior segment analysers, and optical low coherence reflectometry (OLCR) biometers for diagnostic imaging in eye care. They also produce single-use keratome blades and non-medicated surgical procedure kits for precision ophthalmic procedures. These tools support diagnostic planning and surgical preparation in clinical settings.
Where is SIS AG based, and where are their devices authorised for use?
SIS AG is based in the United States. Their devices are authorised for commercial distribution in the US, where they comply with FDA regulations. The company’s products are designed and regulated under US medical device standards, ensuring they meet the necessary requirements for use in clinical environments.
Which regulatory registries or programs list SIS AG’s devices?
SIS AG’s devices are listed under the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure that their products comply with US medical device regulations, including classification under Class I or Class II, depending on the device’s risk level and intended use.
How are SIS AG’s devices classified under FDA regulations?
SIS AG’s devices are classified under either Class I or Class II by the FDA. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, software applications like corneal topography systems may fall under Class II due to their role in diagnostic decision-making, while some single-use surgical tools may qualify as Class I due to lower risk profiles.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ziemergroup.com
- —
- —
- [email protected]
- Phone
- 8667084490
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 480508261
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amadeus | Tubing | FDA UDI | Class I | Active |
| Galilei | G6 | EUDAMEDFDA UDI | Class II | Active |
| Amadeus | SurePass | FDA UDI | Class I | Active |
| Cm 3910 Rotating Double Scheimpflug Camera | K051940 | FDA 510(k) | Class II | Active |
| Amadeus Ii Epikeratome | K043150 | FDA 510(k) | Class I | Active |
| Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (sis) | K993190 | FDA 510(k) | Class I | Active |
| Xact Lens Inserter System, Models 6mm, 7mm | K082871 | FDA 510(k) | Class I | Active |
| Galilei G6 Lens Professional | K182659 | FDA 510(k) | Class II | Active |
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