510(k) · Cleared
ClearedRevitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue Visibility Tint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metro Optics of Austin, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 23, 2008 as substantially equivalent to K964902 (Metro Optics of Austin, Inc., 1997) and 1 other predicate after a 149-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Jul 23, 2008
- Review
- 149 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961943 (1996). 2 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK961943 FlexlensFlexlens, Inc. · 1996
- This deviceK080512 Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon…Metro Optics of Austin, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK100244 Metro SoftMetro Optics of Austin, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK161288 LenSX Laser SystemAlcon Laboratories, Inc. · 2016
- Descendant · 4 generations on · 3 of its ownK163551 LenSx Laser SystemAlcon Laboratories, Inc. · 2017
- Descendant · 5 generations on · 2 of its ownK173660 LenSx Laser SystemAlcon Laboratories, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K100244Metro SoftMetro Optics of Austin, Inc. · 2010 · cites it directly8descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on5descendants
- K161288LenSX Laser SystemAlcon Laboratories, Inc. · 2016 · 3 generations on4descendants
- K163551LenSx Laser SystemAlcon Laboratories, Inc. · 2017 · 4 generations on3descendants
- K173660LenSx Laser SystemAlcon Laboratories, Inc. · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961943 | Flexlens | Flexlens, Inc. | 1996 | — |
| 0 (this device) | K080512 | Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear… | Metro Optics of Austin, Inc. | 2008 | — |
| +1 | K100244 | Metro Soft | Metro Optics of Austin, Inc. | 2010 | — |
| +2 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
| +3 | K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016 | — |
| +4 | K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017 | — |
| +5 | K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K964902 | Contact Lenses Metro-G 3X (Hioxifilcon B)Summary page 2…use and design. Predicate devices include: Metro-G 3X, manufactured by Metro Optics of Austin, K964902 FlexLens Post Refractive Surgery, manufactured by FlexLens, K961943 Device Description: The RevitalEyes, Post-Surg… | 1997 |
| * | K961943 | FlexlensSummary page 2…ices include: Metro-G 3X, manufactured by Metro Optics of Austin, K964902 FlexLens Post Refractive Surgery, manufactured by FlexLens, K961943 Device Description: The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility… | 1996 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100244 | Metro Soft | 2010 | 8 |
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?
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. 2008, 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?
The RevitalEyes, Post-Surgical (Hioxifilcon B) Soft Contact Lenses for daily wear may be prescribed
in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered
corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,
disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the
lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080512: Revitaleyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) Clear and Blue Visibility Tint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080512
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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