CATALYS Precision Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220516 FDA 510(k)
- FDA Product Code
- OOE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CATALYS Precision Laser System is an Ophthalmic Femtosecond Laser, designed for precise corneal and cataract surgical procedures. It employs ultrafast laser technology to perform intricate cuts, incisions, and tissue separations in ophthalmic applications, including refractive surgery and lens extraction.
This device is intended for use in clinical settings by trained ophthalmic professionals. Supplied as a reusable medical instrument, it requires proper maintenance and sterilization protocols as outlined in manufacturer guidelines. The system is classified as a Class 2 device under FDA regulations (product code OOE) and holds a FDA 510K clearance for substantial equivalence in ophthalmic laser applications. No MRI safety information or specific sterility assurances are provided in the available data.
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: Catalys Precision Laser System (K223838) — FDA 510 (k) | Innolitics, Amo Manufacturing USA, LLC FDA 510 (k) Products 2023, K182083 - Catalys Precision Laser System | FDA 510 (k), CATALYS™ precision laser system | J&J Vision Professional
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220516 | Class II | Active |
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Manufacturer
- Manufacturer
- AMO Manufacturing USA, LLC
Sources (1)
- FDA 510(k) K220516 24 fields · synced Sep 18, 2026