Staar Phaco XL Small Incision System
FDA 510(k) K884241 · Staar Surgical Co.
510(k) numberK884241
Submission
- Device name
- Staar Phaco XL Small Incision System
- Applicant
- Staar Surgical Co.
Monrovia, CA, US - Received
- October 11, 1988
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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| K172375 | MicroSTAAR Injector System CartridgesMSS · Special | 09/06/2017SE |
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| K073591 | Microstaar Msi Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K073586 | Microstaar Indigo Injector Foam Tip SystemMSS · Traditional | 03/13/2008SE |
| K032412 | Re-Useable Microstaar Injector, Msi-SKYB · Traditional | 06/10/2004SE |
| K020734 | Surge-Free Aspiration AdapterHQC · Traditional | 05/16/2002SE |
| K983129 | Disposable Microstaar Injector (Model MSI-P1)KYB · Traditional | 12/04/1998SE |
| K980696 | Foam Tip InjectorMSS · Traditional | 09/11/1998SE |
| K954600 | Microstaar Injector Models Msi-Td & Msi-Pd (Modification)KYB · Traditional | 12/21/1995SE |
Questions and answers
When was Staar Phaco XL Small Incision System cleared by the FDA?
Staar Phaco XL Small Incision System (K884241) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 129 days after the submission was received.
What is the product code of K884241?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.