xPORT Lens Fragmentation System
FDA 510(k) K191024 · Carl Zeiss Meditec Cataract Technology, Inc.
510(k) numberK191024
Submission
- Device name
- xPORT Lens Fragmentation System
- Applicant
- Carl Zeiss Meditec Cataract Technology, Inc.
Reno, NV, US - Received
- April 18, 2019
- Decision date
- August 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243395 | MICOR 700 with Auto I/AHQC · Traditional | 08/08/2025SE |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621)…HQC · Traditional | 06/11/2025SE |
| K214028 | MICOR Lens Fragmentation SystemHQC · Traditional | 09/09/2022SE |
| K222236 | miCOR System Lens Fragmentation SystemHQC · Special | 08/24/2022SE |
| K200207 | xPORT S Lens Fragmentation SystemHQC · Traditional | 10/15/2020SE |
| K200584 | xPORT 304 (miCOR) System Lens Fragmentation SystemHQC · Traditional | 07/31/2020SE |
Questions and answers
When was xPORT Lens Fragmentation System cleared by the FDA?
xPORT Lens Fragmentation System (K191024) received a 510(k) decision of Substantially Equivalent on August 13, 2019, 117 days after the submission was received.
What is the product code of K191024?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.