Staar Phaco Xl Small Incision System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K884241 FDA 510(k)
- FDA Product Code
- HQC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4670 FDA 510(k)
- Regulation Number
- 886.4670 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STAAR PHACO XL SMALL INCISION SYSTEM is a device for phacofragmentation, a process that breaks up the lens of the eye. It is intended for use in ophthalmic surgery.
The device is supplied sterile and is intended for single use. It is not reusable. The device is not indicated for use in MRI environments. The device is regulated as a Class II medical device.
Frequently asked questions
What is the STAAR PHACO XL Small Incision System used for?
It is a device for phacofragmentation, which breaks up the lens of the eye, intended for use in ophthalmic surgery.
Is the STAAR PHACO XL Small Incision System reusable?
No, the device is intended for single use and is not reusable.
How is the STAAR PHACO XL Small Incision System supplied?
The device is supplied sterile and is intended for single use.
Is the STAAR PHACO XL Small Incision System indicated for use in MRI environments?
No, the device is not indicated for use in MRI environments.
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: Homepage - Staar Surgical, K884241 FDA 510 (k) - STAAR PHACO XL SMALL INCISION SYSTEM, Homepage - Staar Surgical, STAAR PHACO XL SMALL INCISION SYSTEM 510(k) K884241 - FDA.report, STAAR PHACO XL SMALL INCISION SYSTEM 510(k) K884241 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884241 | Class II | Active |
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Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (1)
- FDA 510(k) K884241 24 fields · synced Sep 26, 2026