510(k) · Cleared
ClearedFreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 3, 2018 as substantially equivalent to P830037 (Alcon Laboratories, Inc., 1984) after a 29-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Aug 3, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P830037 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backP830037 Durasoft (R) 3 for Ext WearAlcon Laboratories, Inc. · 1984 · Recalled
- This deviceK181796 FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends…Alcon Laboratories, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P830037 | Durasoft (R) 3 for Ext Wear | Alcon Laboratories, Inc. | 1984 | 2 |
| 0 (this device) | K181796 | FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook… | Alcon Laboratories, Inc. | 2018 | — |
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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | P830037 | Durasoft (R) 3 for Ext WearSummary page 4…Look Colors, FreshLook ColorBlends and FreshLook Dimensions (phemfilcon A) soft contact lenses, which are legally commercialized devices in the US under 510(k) P830037. IV. Device Description FreshLook (phemfilcon A) are a family of soft contact lenses, intended for the optical correct… | 1984 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate P830037.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
FreshLook Spherical (phemfilcon A) soft (hydrophilic) contact lenses are indicated for the correction of visual acuity in persons with nondiseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.
The FreshLook Spherical Colors, ColorBlends, and Dimensions lenses act to enhance or alter the apparent color of the eye.
The eye care professional may prescribe the lens for frequent replacement with daily removal for cleaning and disinfection. The lens may be disinfected using a chemical disinfection system.
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/K181796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181796: FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181796
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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