510(k) · Cleared
ClearedBonasse Contact Lens Case
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonasse Ent. Co., Ltd. · LRX Case, Contact Lens
Cleared on Jun 6, 2000 after a 424-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 6, 2000
- Review
- 424 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK991206 Bonasse Contact Lens CaseBonasse Ent. Co., Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK130285 Progent Large Diameter Contact Lens Case for Rigid Gas Permeable LensThe Lagado Corp. · 2013
- Descendant · cites it directly · 0 of its ownK111856 Soft Grip Contact Lens Case, Deluxe Contact Lens Case, Econo-Mate…Apothecary Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK090362 Imag, Ipod, EZ-Find and IslideVoguestrap · 2009
Most influential descendants
Showing 3 of 3 · See all- K130285Progent Large Diameter Contact Lens Case for Rigid Gas Permeable LensThe Lagado Corp. · 2013 · cites it directly0descendants
- K111856Soft Grip Contact Lens Case, Deluxe Contact Lens Case, Econo-Mate Contact Lens CaseApothecary Products, Inc. · 2011 · cites it directly0descendants
- K090362Imag, Ipod, EZ-Find and IslideVoguestrap · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991206 | Bonasse Contact Lens Case | Bonasse Ent. Co., Ltd. | 2000 | — |
| +1 | K130285 | Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens | The Lagado Corp. | 2013 | — |
| +1 | K111856 | Soft Grip Contact Lens Case, Deluxe Contact Lens Case, Econo-Mate Contact Lens… | Apothecary Products, Inc. | 2011 | — |
| +1 | K090362 | Imag, Ipod, EZ-Find and Islide | Voguestrap | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 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 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 |
|---|---|---|---|
| * | — | Alcon Opti-Free contact lens case Named without a submission number |
What descends from it? (3)
3 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?
- Of its descendants, K130285 (The Lagado Corp., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LRX devicesLRX Case, Contact Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For storage of soft (hydrophilic), rigid gas permeable (RGP), and 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991206: Bonasse Contact Lens Case.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991206
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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