INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE— 510(k) K112425
Substantially EquivalentAlcon Manufacturing, Ltd.
FDA 510(k) clearance K112425 for INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE, Substantially Equivalent on 2011-11-21. Applicant: Alcon Manufacturing, Ltd.. Device class: 2.
Clearance details
- Applicant
- Alcon Manufacturing, Ltd.
- 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
- Irvine, CA, US
Recent devices under product code HQC
view all- K261264 — Stellaris Elite vision enhancement system +7 more
- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- 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 Manufacturing, Ltd.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.