510(k) · Cleared
ClearedAMB101 System, Amblyz, LCG System, Xpand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X6d, Ltd. · HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Cleared on Apr 28, 2014 as substantially equivalent to K050856 (Ophthocare, Ltd., 2005) after a 300-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Apr 28, 2014
- Review
- 300 days
- Class
- Class I
- Product code
- HOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050856 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK050856 LCG (Liquide Crystal Glasses) SystemOphthocare, Ltd. · 2005
- This deviceK132042 AMB101 System, Amblyz, LCG System, XpandX6d, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050856 | LCG (Liquide Crystal Glasses) System | Ophthocare, Ltd. | 2005 | — |
| 0 (this device) | K132042 | AMB101 System, Amblyz, LCG System, Xpand | X6d, Ltd. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K050856 | LCG (Liquide Crystal Glasses) SystemSummary page 1…Regulation Number: 686.4750 Panel: Ophthalmic Predicate Devices: LCG (Liquid Crystal Glasses) System; cleared under K050856; Product Code HaY; Regulation Number 886.4750 Intended Use / Indication for Use: The Amblyz T M System is an electronic shu… | 2005 |
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.
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. 2014, this device’s year, is highlighted.
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 AmblyzTM 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/K132042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132042: AMB101 System, Amblyz, LCG System, Xpand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132042
Report an extraction error
Are you the manufacturer?
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