PMA · Approved
ApprovedOpti-Zyme Enzymatic Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories · LPN Accessories, Soft Lens Products
Approved on May 15, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 148-day review. 4 later devices descend from it.
- Decided
- May 15, 1997
- Review
- 148 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
4 later devices descend from it, 1 citing it directly.
- This deviceP820001/
S021 Opti-Zyme Enzymatic CleanerAlcon Laboratories · 1997 - Descendant · cites it directly · 3 of its ownK973217 Boston Liquid Enzymatic CleanerPolymer Technology Corp. · 1997
- Descendant · 2 generations on · 2 of its ownK181627 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb…Bausch & Lomb, Incorporated · 2018
- Descendant · 3 generations on · 0 of its ownK251876 cleadew GP hydra oneOphtecs Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK200416 Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated · 2020
Most influential descendants
Showing 4 of 4 · See all- K973217Boston Liquid Enzymatic CleanerPolymer Technology Corp. · 1997 · cites it directly3descendants
- K181627Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…Bausch & Lomb, Incorporated · 2018 · 2 generations on2descendants
- K251876cleadew GP hydra oneOphtecs Corporation · 2025 · 3 generations on0descendants
- K200416Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P820001/ | Opti-Zyme Enzymatic Cleaner | Alcon Laboratories | 1997 | — |
| +1 | K973217 | Boston Liquid Enzymatic Cleaner | Polymer Technology Corp. | 1997 | — |
| +2 | K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One… | Bausch & Lomb, Incorporated | 2018 | — |
| +3 | K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025 | — |
| +3 | K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973217 | Boston Liquid Enzymatic Cleaner | 1997 | 3 |
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.
What does this lineage say?
- Of its descendants, K973217 (Polymer Technology Corp., 1997) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/P820001/S021 · printed Nov 6, 2026
Cite this page
510(k) Report. “P820001/S021: Opti-Zyme Enzymatic Cleaner.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P820001/S021
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026