510(k) · Cleared
ClearedImag, Ipod, EZ-Find and Islide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voguestrap · LRX Case, Contact Lens
Cleared on Feb 27, 2009 as substantially equivalent to K991206 (Bonasse Ent. Co., Ltd., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 27, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991206 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK991206 Bonasse Contact Lens CaseBonasse Ent. Co., Ltd. · 2000
- This deviceK090362 Imag, Ipod, EZ-Find and IslideVoguestrap · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991206 | Bonasse Contact Lens Case | Bonasse Ent. Co., Ltd. | 2000 | — |
| 0 (this device) | K090362 | Imag, Ipod, EZ-Find and Islide | Voguestrap | 2009 | — |
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 LRX? 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 LRX device
- #1 K240095 CAREUS Contact Lens Case (Model 1, Model 2…score 15.3 · 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 |
|---|---|---|---|
| * | K991206 | Bonasse Contact Lens CaseSummary page 1…uct Code: LRX 3. Common or Usual Name: Contact Lens Case 4. Predicate Device Information: Bonasse Contact Lens case K991206 5. Device Description: The Voguestrap Contact Lens Cases are plastic cases designed such that they are flat s… | 2000 |
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.
- 2 other devices also cite its predicate K991206.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRX
49in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRX
No recall names LRX since 2007.
Adverse event reports per year · LRX
1in 2021
MAUDE reports naming product code LRX, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 103 | 0 | 1 |
| 2013 | 4 | 72 | 0 | 0 |
| 2014 | 3 | 249 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 5 | 49 | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Voguestrap Contact Lens Cases are intended for the storage of soft (hydrophilic), rigid gas permeable (RGP), or hard contact lenses during chemical disinfection. For use in storage during chemical disinfection only. Not to be used with hydrogen peroxide disinfection systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090362: Imag, Ipod, EZ-Find and Islide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090362
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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