OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION— 510(k) K021143
Substantially EquivalentAlcon Universal, Ltd.
FDA 510(k) clearance K021143 for OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION, Substantially Equivalent on 2002-08-08. Applicant: Alcon Universal, Ltd.. Device class: 2.
Clearance details
- Applicant
- Alcon Universal, Ltd.
- Product code
- Code LPN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code LPN
view allMore clearances from Alcon Universal, Ltd.
view allAdverse events under product code LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
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 K021143
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021143.
Data sourced from openFDA. This site is unofficial and independent of the FDA.