PMA · Approved
ApprovedX-70 Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Optics, Inc. · LPM Lenses, Soft Contact, Extended Wear
Approved on Mar 29, 1985 through premarket approval, which rests on the device’s own clinical evidence after a 610-day review. 34 later devices descend from it.
- Decided
- Mar 29, 1985
- Review
- 610 days
- Class
- Class III
- Product code
- LPM
- Recalls
- None
34 later devices descend from it, 1 citing it directly.
- This deviceP830047 X-70 Soft Contact LensAdvanced Medical Optics, Inc. · 1985
- Descendant · cites it directly · 33 of its ownK983637 Actifresh 400 LensHydron, Ltd. · 1999
- Descendant · 2 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- Descendant · 3 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
- Descendant · 4 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015
- Descendant · 5 generations on · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K983637Actifresh 400 LensHydron, Ltd. · 1999 · cites it directly33descendants
- K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 2 generations on32descendants
- K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 3 generations on12descendants
- K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 4 generations on11descendants
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P830047 | X-70 Soft Contact Lens | Advanced Medical Optics, Inc. | 1985 | — |
| +1 | K983637 | Actifresh 400 Lens | Hydron, Ltd. | 1999 | — |
| +2 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| +3 | K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015 | — |
| +4 | K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens… | Art Optical Contact Lens, Inc. | 2015 | — |
| +5 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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 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 LPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983637 | Actifresh 400 Lens | 1999 | 33 |
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, K983637 (Hydron, Ltd., 1999) has gone furthest, with 33 descendants of its own.
How does its category compare?
All LPM devicesLPM Lenses, Soft Contact, Extended Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPM
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPM
Too few LPM 510(k)s in any year since 2007 to give a median.
Recalls per year · LPM
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPM
111in 2025
MAUDE reports naming product code LPM, 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 | — | 1 | 68 |
| 2008 | 15 | — | 0 | 42 |
| 2009 | 12 | — | 0 | 56 |
| 2010 | 30 | — | 3 | 108 |
| 2011 | 51 | — | 0 | 155 |
| 2012 | 49 | — | 0 | 181 |
| 2013 | 31 | — | 0 | 172 |
| 2014 | 26 | — | 3 | 111 |
| 2015 | 35 | — | 0 | 143 |
| 2016 | 43 | — | 0 | 220 |
| 2017 | 79 | — | 1 | 215 |
| 2018 | 59 | — | 1 | 195 |
| 2019 | 55 | — | 0 | 189 |
| 2020 | 45 | — | 0 | 107 |
| 2021 | 28 | — | 0 | 103 |
| 2022 | 40 | — | 0 | 82 |
| 2023 | 15 | — | 0 | 118 |
| 2024 | 31 | — | 0 | 163 |
| 2025 | 31 | — | 0 | 111 |
| 2026 | 23 | — | 0 | — |
https://510kreport.com/device/P830047 · printed Nov 6, 2026
Cite this page
510(k) Report. “P830047: X-70 Soft Contact Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P830047
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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