Katalyst Laser Probes, Katalyst Illuminated Laser Probes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121187 FDA 510(k)
- FDA Product Code
- HQF 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 Katalyst Laser Probes and Katalyst Illuminated Laser Probes are ophthalmic laser devices designed for use in surgical procedures. These probes are engineered to deliver laser energy within a wavelength range of 500 nm to 900 nm, facilitating precise tissue interaction in ocular applications. The illuminated variant incorporates a light source to enhance visibility during procedures, improving surgical precision and control.
These probes are supplied in sterile, disposable packaging, with each box containing ten units. They are classified as Class II medical devices under FDA regulations (Regulation Number 886.4390) and have received a 510(k) clearance through the Traditional pathway. The devices are intended for reusable and single-use scenarios, depending on the specific model and surgical requirements, though the illuminated variant is explicitly marketed as disposable. No MRI safety information is specified, and storage conditions are not detailed in the available data.
Frequently asked questions
What is the Katalyst Illuminated Laser Probe used for in ophthalmic surgery?
The Katalyst Illuminated Laser Probe is designed for delivering laser energy (wavelength range: 500–900 nm) during ocular surgical procedures. The illuminated variant includes a built-in light source to improve visibility of the surgical field, helping surgeons achieve greater precision and control when interacting with tissue. This is particularly useful in procedures requiring fine manipulation, such as certain laser-assisted surgeries.
Are the Katalyst Laser Probes single-use or reusable, and how are they packaged?
The Katalyst Laser Probes come in both single-use and reusable configurations, depending on the specific model. The Katalyst Illuminated Laser Probes are explicitly marketed as disposable and are supplied in sterile, disposable packaging. Each box contains ten individually sterile probes, ensuring readiness for immediate use without reprocessing.
What are the key specifications for the wavelength and regulatory classification of these probes?
The Katalyst Laser Probes and Katalyst Illuminated Laser Probes operate within a wavelength range of 500 nm to 900 nm, enabling precise tissue interaction in ocular applications. Regulatory classification in the U.S. is as Class II medical devices under FDA regulation number 886.4390. They received 510(k) clearance through the Traditional pathway, confirming their substantial equivalence to predicate devices.
How should the Katalyst Illuminated Laser Probes be stored, and are there any MRI safety considerations?
The storage conditions for the Katalyst Illuminated Laser Probes are not explicitly detailed in the available data. However, as they are supplied in sterile, disposable packaging, it is recommended to follow standard protocols for sterile surgical instruments, including protection from contamination and extreme temperatures. No MRI safety information is specified for these probes, so their use in MRI environments should be evaluated based on individual facility protocols and manufacturer guidelines.
What distinguishes the Katalyst Illuminated Laser Probes from standard Katalyst Laser Probes?
The Katalyst Illuminated Laser Probes differ from standard Katalyst Laser Probes by incorporating an integrated light source. This feature enhances visibility during surgery, allowing surgeons to better visualize the target tissue and improve precision. While both probe types deliver laser energy within the 500–900 nm range, the illuminated variant is specifically designed for disposable use, whereas the standard probes may be used in reusable applications depending on clinical requirements.
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: Laser Probes | Katalyst Surgical, Katalyst Laser Probes, Katalyst Illuminated Laser Probes (K121187 ..., Laser Probes Katalyst | M.I.S.S Ophthalmics, KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES - beudamed.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121187 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Katalyst Surgical, Llc
Sources (1)
- FDA 510(k) K121187 24 fields · synced Oct 1, 2026