Catalys Precision Laser System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- CATALYS PRECISION LASER SYSTEM EUDAMED
- Device Name
- CATALYS SYSTEM EUDAMED
- Model / Reference
- CATALYS-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05050474604797 EUDAMED
- Basic UDI-DI
- 5050474a000089G EUDAMED
- Direct Marketing DI
- 05050474604797 EUDAMED
- 510(k) Number
- K223838 FDA 510(k)
- FDA Product Code
- OOE FDA 510(k)
- EMDN Code
- Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Catalys Precision Laser System is an ophthalmic femtosecond laser designed for precise corneal and lens procedures. It delivers ultra-short laser pulses to perform intricate cuts and incisions in ocular tissues, supporting applications such as refractive surgery, cataract surgery, and corneal transplant preparation.
This device is intended for use in sterile operating environments and is classified as a reusable medical instrument. It is regulated under FDA 510(k) clearance (K223838) and MDR, adhering to Class II (product code OOE) standards for ophthalmic devices. Storage and handling follow manufacturer guidelines to maintain sterility and functionality, with no specific MRI safety restrictions noted.
Frequently asked questions
What types of eye procedures is the Catalys Precision Laser System designed to assist with?
The Catalys Precision Laser System is specifically engineered for ophthalmic applications involving precise corneal and lens procedures. It supports refractive surgery, cataract surgery, and preparation for corneal transplants by delivering ultra-short laser pulses to create intricate cuts and incisions in ocular tissues.
Is the Catalys Precision Laser System intended for single-use or reusable applications?
The device is classified as a reusable medical instrument, meaning it is designed for repeated use in sterile operating environments. Proper storage and handling per manufacturer guidelines are required to maintain sterility and functionality between procedures.
What regulatory pathways has the Catalys Precision Laser System followed for approval?
The system has undergone FDA 510(k) clearance (K223838) and adheres to the EU Medical Device Regulation (MDR). It is classified under FDA product code OOE as a Class II ophthalmic device, with a determination of substantial equivalence to prior-generation technology.
Are there any special storage or handling requirements for the Catalys Precision Laser System?
While the device does not specify MRI safety restrictions, it must be stored and handled according to manufacturer guidelines to preserve sterility and functionality. Since it is reusable, adherence to sterile protocols between uses is critical for safe clinical operation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K182083 - Catalys Precision Laser System | FDA 510 (k), Catalys Precision Laser System (K223838) — FDA 510 (k) | Innolitics, Amo Manufacturing USA, LLC FDA 510 (k) Products 2023, Catalys Precision Laser System 510(k) K182083 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223838 | Class II | Active |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
Sources (2)
- FDA 510(k) K223838 24 fields · synced Sep 18, 2026
- EUDAMED 94a5f637-ae9a-4bf1-b036-a952fc684ecb 61 fields · synced Jul 19, 2026