INFINITI— 510(k) K021566
Substantially EquivalentAlcon Laboratories, Inc.
FDA 510(k) clearance K021566 for INFINITI, Substantially Equivalent on 2002-07-02. Applicant: Alcon Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Alcon Laboratories, Inc.
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code HQC
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- K250501 — System Sophi
- K243395 — MICOR 700 with Auto I/A
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
More clearances from Alcon Laboratories, Inc.
view allAdverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K021566
K-number listed on FDA's recall record- Z-2408-2023 — Infinity FMS Pak
- Z-2834-2016 — LAUREATE World Phaco System
- Z-1597-2016 — INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021566.
Data sourced from openFDA. This site is unofficial and independent of the FDA.