510(k) · Cleared
ClearedOpti-Free Supraclens Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392
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 Jun 22, 1998 after an 84-day review; its predicate, P830071, is listed below.
- Decided
- Jun 22, 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P82002 | Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover Number could not be read Summary page 2…l Equivalence: This product is substantlally equivalent, in terms of its actions and indications for use, to the Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 82002/818)/OPTI -SOAK™ Conditioning Solution (PMA 830071/S08) combination. The OPTI- FREE® SUPRACLENS® Daily Protein Remover/Alcon Wett… | |
| * | P830071 | Improved Soaclens FDA lists this PMA only through its supplements; the earliest we hold is P830071/S002 (Dec 30, 1987). Summary page 2…valent, in terms of its actions and indications for use, to the Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 82002/818)/OPTI -SOAK™ Conditioning Solution (PMA 830071/S08) combination. The OPTI- FREE® SUPRACLENS® Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solutio… |
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?
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE Multi-Purpose Solution, or OPTI-FREE® EXPRESS Multi-Purpose Solution or…
Read the full statement (139 words)
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE Multi-Purpose Solution, or OPTI-FREE® EXPRESS Multi-Purpose Solution or conditioned in OPTI-SOAK Conditioning Solution or Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392. Use as recommended by your eye care practitioner.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is for the disinfection and conditioning after cleaning and rinsing of clear and tinted, daily and extended wear fluorosilicone acrylate and silicone acrylate rigid gas permeable lenses.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
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/K981151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981151: Opti-Free Supraclens Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981151
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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