510(k) · Cleared
ClearedLiquid Enzyme ID 90133
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · LPN Accessories, Soft Lens Products
Cleared on Jul 24, 1998 after an 84-day review; the summary names 2 predicates, listed below.
- Decided
- Jul 24, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPN device
- #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P820001 | Opti-Zyme (TM) Enzyamtic Cleaner FDA lists this PMA only through its supplements; the earliest we hold is P820001/S006 (Jun 4, 1984). Summary page 2…ntial Equivalence: This product is substantially equivalent, in terms of its actions and indications for use, to Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 820001/S18), OPTI-FREE® EXPRESS® (PMA 830034/S27) and OPTI-FREE® Rinsing, Disinfection and Storage Solution. (PMA 830034/S03). Liquid En… | |
| * | P830034 | Polyquat Disinfection System FDA lists this PMA only through its supplements; the earliest we hold is P830034/S001 (Oct 22, 1985). Summary page 2…bstantially equivalent, in terms of its actions and indications for use, to Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 820001/S18), OPTI-FREE® EXPRESS® (PMA 830034/S27) and OPTI-FREE® Rinsing, Disinfection and Storage Solution. (PMA 830034/S03). Liquid Enzyme ID 90133 meets the guidelines set… |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Liquid Enzyme ID 90133 is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Use as recommended by your eye care practitioner. OPTI-FREE® EXPRESS® Multi-Purpose Solution is for use in chemical (not heat) disinfection and for cleaning…
Read the full statement (146 words)
Liquid Enzyme ID 90133 is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Use as recommended by your eye care practitioner.
OPTI-FREE® EXPRESS® Multi-Purpose Solution is for use in chemical (not heat) disinfection and for cleaning, rinsing, disinfecting and storing of clear and tinted, daily and extended wear soft (hydrophilic) contact lenses.
OPTI-FREE® EXPRESS® Multi-Purpose Solution can also be used as a diluent for Liquid Enzyme ID 90133.
OPTI-FREE® Rinsing, Disinfecting and Storage Solution is for use in chemical (not heat) disinfection and for rinsing, disinfecting and storing of clear and tinted, daily and extended wear soft (hydrophilic) contact lenses.
OPTI-FREE® Rinsing, Disinfecting and Storage Solution can also be used as a diluent for Liquid Enzyme ID 90133.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981561 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981561: Liquid Enzyme ID 90133.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981561
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026