510(k) · Cleared
ClearedCrystal Custom Tinted Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crystal Reflections, Int., Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 14, 2000 as substantially equivalent to K984098 (Adventures IN Color Technology, Ltd., 1999) after a 182-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 14, 2000
- Review
- 182 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984098 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK984098 Adventure Tints, Color Enhanced Tinted Soft Contact LensAdventures IN Color Technology, Ltd. · 1999
- This deviceK993489 Crystal Custom Tinted Soft Contact LensCrystal Reflections, Int., Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984098 | Adventure Tints, Color Enhanced Tinted Soft Contact Lens | Adventures IN Color Technology, Ltd. | 1999 | — |
| 0 (this device) | K993489 | Crystal Custom Tinted Soft Contact Lens | Crystal Reflections, Int., Inc. | 2000 | — |
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 |
|---|---|---|---|
| * | K984098 | Adventure Tints, Color Enhanced Tinted Soft Contact LensSummary page 5…lowing "legally marketed predicate device": PREDICATE DEVICE: Manufacturer: Adventures in Colors, Inc. Device names: Adventure Tints, Color Enhanced Soft Contact Lens (K984098) 510(k) Summary Characteristic CRYSTAL TINTED SOFT PREDICATE CONTACT LENS DEVICE 1.) INDICATION Daily Wear, Soft… | 1999 |
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 no 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.
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 Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. Except for decreased light transmittance due to the tint intensity, the pre- tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only. The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the…
Read the full statement (116 words)
The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance
and/or alter the apparent eye color.
Except for decreased light transmittance due to the tint intensity, the pre-
tinted lens optical parameters remain the same as originally prescribed for
the user prior to tinting. The lens may be disinfected using a chemical
disinfection system only.
The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance
and/or alter the apparent eye color.
Except for decreased light transmittance due to the tint intensity, the pre-
tinted lens optical parameters remain the same as originally prescribed for
the user prior to tinting. The lens may be disinfected using a chemical
disinfection system only.
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/K993489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993489: Crystal Custom Tinted Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993489
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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