510(k) · Cleared
ClearedNovelens Contact Lens Cleaning Enhancement and Storage Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novelens, Inc. · LRX Case, Contact Lens
Cleared on Dec 4, 2003 as substantially equivalent to K013232 (Bausch & Lomb, Inc., 2001) and 4 other predicates after a 132-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Dec 4, 2003
- Review
- 132 days
- Class
- Class II
- Product code
- LRX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K915082 (1992). 7 ancestors in all, the oldest K852384 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK915082 Opti-Lens (TM) Contact Lens CaseRyder Intl. Corp. · 1992
- 2 generations backK971618 Alcon Contact Lens CaseAlcon Laboratories · 1997
- 1 generation backK974281 Alcon Contact Lens CaseAlcon Laboratories · 1998
- This deviceK032309 Novelens Contact Lens Cleaning Enhancement and Storage AccessoryNovelens, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915082 | Opti-Lens (TM) Contact Lens Case | Ryder Intl. Corp. | 1992 | — |
| −2 | K971618 | Alcon Contact Lens Case | Alcon Laboratories | 1997 | — |
| −1 | K974281 | Alcon Contact Lens Case | Alcon Laboratories | 1998 | — |
| 0 (this device) | K032309 | Novelens Contact Lens Cleaning Enhancement and Storage Accessory | Novelens, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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? (5)
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 |
|---|---|---|---|
| * | K013232 | Cybercases by Bausch & LombSummary page 1…Class II: LRX ESTABLISHMENT REGISTRATION: PENDING SUBSTANTIALLY EQUIVALENT TO: The NoveLens® Contact Lens Case is substantially equivalent to the following devices: K013232 Bausch & Lomb CyberCase Contact Lens Case K852384 Basuch & Lomb CyberCase Contact Lens Case K971618 Alcon… | 2001 |
| * | K852384 | Sight Saver All Purpose Lens Carrying CaseSummary page 1…ANTIALLY EQUIVALENT TO: The NoveLens® Contact Lens Case is substantially equivalent to the following devices: K013232 Bausch & Lomb CyberCase Contact Lens Case K852384 Basuch & Lomb CyberCase Contact Lens Case K971618 Alcon Contact Lens Case K974281 Alcon Contact Lens Case… | 1985 |
| * | K971618 | Alcon Contact Lens CaseSummary page 1…s substantially equivalent to the following devices: K013232 Bausch & Lomb CyberCase Contact Lens Case K852384 Basuch & Lomb CyberCase Contact Lens Case K971618 Alcon Contact Lens Case K974281 Alcon Contact Lens Case K021248 iCase: IKeeps, Inc, DESCRIPTION of the… | 1997 |
| * | K974281 | Alcon Contact Lens CaseSummary page 1…ing devices: K013232 Bausch & Lomb CyberCase Contact Lens Case K852384 Basuch & Lomb CyberCase Contact Lens Case K971618 Alcon Contact Lens Case K974281 Alcon Contact Lens Case K021248 iCase: IKeeps, Inc, DESCRIPTION of the DEVICE: The NoveLens® Contact Lens Case… | 1998 |
| * | K021248 | ICASESummary page 1…omb CyberCase Contact Lens Case K852384 Basuch & Lomb CyberCase Contact Lens Case K971618 Alcon Contact Lens Case K974281 Alcon Contact Lens Case K021248 iCase: IKeeps, Inc, DESCRIPTION of the DEVICE: The NoveLens® Contact Lens Case is a contact lens storage case comprise… | 2002 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K013232.
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?
The NoveLens® Contact Lens Case is indicated for storage of hard, rigid gas permeable
(silicone acrylate and fluro silicone acrylate) and soft (hydrophilic) contact lenses during
chemical disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032309: Novelens Contact Lens Cleaning Enhancement and Storage Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032309
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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