510(k) · Cleared
ClearedCybercases by Bausch & Lomb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LRX Case, Contact Lens
Cleared on Nov 20, 2001 as substantially equivalent to K852384 (Bausch & Lomb, Inc., 1985) after a 54-day review. Its family tree reaches back 1 generation to 1985. 4 later devices descend from it.
- Decided
- Nov 20, 2001
- Review
- 54 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852384 (1985). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK852384 Sight Saver All Purpose Lens Carrying CaseBausch & Lomb, Inc. · 1985
- This deviceK013232 Cybercases by Bausch & LombBausch & Lomb, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK231123 Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK173365 Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK040914 Polyvial/Polypak, Contact Lens Case and Storage System Container for…Exero Products, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK032309 Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -…Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. · 2023 · cites it directly0descendants
- K173365Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated · 2017 · cites it directly0descendants
- K040914Polyvial/Polypak, Contact Lens Case and Storage System Container for OphthalmicsExero Products, Inc. · 2004 · cites it directly0descendants
- K032309Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852384 | Sight Saver All Purpose Lens Carrying Case | Bausch & Lomb, Inc. | 1985 | — |
| 0 (this device) | K013232 | Cybercases by Bausch & Lomb | Bausch & Lomb, Inc. | 2001 | — |
| +1 | K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens… | Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. | 2023 | — |
| +1 | K173365 | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | 2017 | — |
| +1 | K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | Exero Products, Inc. | 2004 | — |
| +1 | K032309 | Novelens Contact Lens Cleaning Enhancement and Storage Accessory | Novelens, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 15.4 · 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 |
|---|---|---|---|
| * | K852384 | Sight Saver All Purpose Lens Carrying CaseSummary page 2…of indications for use, safety and effectiveness to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case, cleared for marketing under 510(k) Notification #K852384 on 7/31/1985. The addition of different colorants to the lens case does not effect the use of this product. 320 === Page 3 ==… | 1985 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case -… | 2023 | 0 |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | 2017 | 0 |
| K040914 | Polyvial/Polypak, Contact Lens Case and Storage System Container for Ophthalmics | 2004 | 0 |
| K032309 | Novelens Contact Lens Cleaning Enhancement and Storage Accessory | 2003 | 0 |
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?
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?
CyberCases by Bausch & Lomb are indicated for use in the storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection
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/K013232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013232: Cybercases by Bausch & Lomb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013232
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026