510(k) · Cleared
ClearedRefresh Optive Lens Comfort Rewetting Drops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · LPN Accessories, Soft Lens Products
Cleared on Jul 9, 2009 as substantially equivalent to K992028 (Allergan, Inc., 1999) after a 199-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jul 9, 2009
- Review
- 199 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P910075/
- Root · 2 generations backP910075/
S007 Complete Brand Lubricating and Rewetting DropsAdvanced Medical Optics, Inc. · 1996 - 1 generation backK992028 Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 1999 · Recalled
- This deviceK083812 Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK190674 REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K190674REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P910075/ | Complete Brand Lubricating and Rewetting Drops | Advanced Medical Optics, Inc. | 1996 | — |
| −1 | K992028 | Refresh Contacts Lubricating and Rewetting Drops | Allergan, Inc. | 1999 | 1 |
| 0 (this device) | K083812 | Refresh Optive Lens Comfort Rewetting Drops | Allergan, Inc. | 2009 | — |
| +1 | K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K992028 | Refresh Contacts Lubricating and Rewetting DropsSummary page 1…ing Drops 3. Predicate Device The predicate device is Allergan REFRESH® Contacts Lubricating and Rewetting Drops which was cleared under K992028. 4. Description of device REFRESH® OPTIVETM Contacts Lubricating and Rewetting Drops is a sterile,… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190674 | REFRESH RELIEVA For CONTACTS | 2019 | 0 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K190674 (Allergan, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K992028.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Use REFRESH® OPTIVETM Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083812: Refresh Optive Lens Comfort Rewetting Drops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083812
Report an extraction error
Are you the manufacturer?
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