510(k) · Cleared
ClearedLCG (Liquide Crystal Glasses) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthocare, Ltd. · HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Cleared on May 31, 2005 after a 56-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 31, 2005
- Review
- 56 days
- Class
- Class I
- Product code
- HOY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050856 LCG (Liquide Crystal Glasses) SystemOphthocare, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK132042 AMB101 System, Amblyz, LCG System, XpandX6d, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132042AMB101 System, Amblyz, LCG System, XpandX6d, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050856 | LCG (Liquide Crystal Glasses) System | Ophthocare, Ltd. | 2005 | — |
| +1 | K132042 | AMB101 System, Amblyz, LCG System, Xpand | X6d, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 HOY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Strabismoscope Undirectional Occluder, Welch Allyn, Inc. Named without a submission number | |
| * | — | Coverlet Eye Occlusion, Beiersdorf, Inc. Named without a submission number | |
| * | — | Spectacle frame Named without a submission number | |
| * | — | Prescription (non-custom) spectacle lens Named without a submission number | |
| * | — | Sunglasses (nonprescription) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132042 | AMB101 System, Amblyz, LCG System, Xpand | 2014 | 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?
- Of its descendants, K132042 (X6d, Ltd., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HOY devicesHOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOY
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HOY
Too few HOY 510(k)s in any year since 2007 to give a median.
Recalls per year · HOY
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HOY
2in 2025
MAUDE reports naming product code HOY, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050856: LCG (Liquide Crystal Glasses) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050856
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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