510(k) · Cleared
ClearedActifresh 400 Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydron, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Dec 10, 1999 as substantially equivalent to P830047 (Advanced Medical Optics, Inc., 1985) after a 420-day review. Its family tree reaches back 1 generation to 1985. 33 later devices descend from it.
- Decided
- Dec 10, 1999
- Review
- 420 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P830047 (1985). 33 later devices descend from it, 7 citing it directly.
- Root · 1 generation backP830047 X-70 Soft Contact LensAdvanced Medical Optics, Inc. · 1985
- This deviceK983637 Actifresh 400 LensHydron, Ltd. · 1999
- Descendant · cites it directly · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · 2 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- Descendant · 3 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
- Descendant · 4 generations on · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
- Descendant · cites it directly · 8 of its ownK100244 Metro SoftMetro Optics of Austin, Inc. · 2010
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · cites it directly32descendants
- K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 2 generations on12descendants
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 3 generations on11descendants
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · 4 generations on8descendants
- K100244Metro SoftMetro Optics of Austin, Inc. · 2010 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P830047 | X-70 Soft Contact Lens | Advanced Medical Optics, Inc. | 1985 | — |
| 0 (this device) | K983637 | Actifresh 400 Lens | Hydron, Ltd. | 1999 | — |
| +1 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +2 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| +3 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
| +4 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
| +1 | K100244 | Metro Soft | Metro Optics of Austin, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 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? (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 |
|---|---|---|---|
| * | P830047 | X-70 Soft Contact LensSummary page 1…ic) Contact Lens for Daily Wear is equivalent to Hydron Omuiflex SofBlue (lidofilcon A) Hydrophilic Contact Lens for Daily Wear approved by the FDA under PMA application P830047 Suppl 6, April 1991. ActiFresh 400 (lidofilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is substantially equivalent to… | 1985 |
What descends from it? (33)
See all 337 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 no recall.
- Of its descendants, K100221 (Art Optical Contact Lens, Inc., 2010) has gone furthest, with 32 descendants of its own.
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.
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 Hydron ActiFresh 400 (lidofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters.
Eyecare practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide 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/K983637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983637: Actifresh 400 Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983637
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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