510(k) · Cleared
ClearedHidrocor, Hidrocharme, and Natural Colors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solotica · LPL Lenses, Soft Contact, Daily Wear
Cleared on Aug 10, 2016 after a 173-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 10, 2016
- Review
- 173 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2016, 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 Hidrocor, Hidrocharme, and Natural Colors Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare…
Read the full statement (155 words)
The Hidrocor, Hidrocharme, and Natural Colors Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K160472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160472: Hidrocor, Hidrocharme, and Natural Colors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160472
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)
- Page last updated Nov 3, 2026