510(k) · Cleared
ClearedLIGHTMED Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightmed USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 1, 2019 as substantially equivalent to K170761 (Lightmed USA, Inc., 2018) after a 227-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Jul 1, 2019
- Review
- 227 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K843696 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK843696 Ophthalmic a-Scan a-2000 SonomeSonomed Technology, Inc. · 1985
- 3 generations backK040668 E-Z Scan AB5500+Sonomed, Inc. · 2004
- 2 generations backK140199 VUPADSonomed, Inc. · 2014
- 1 generation backK170761 LIGHTSonic BUBMLightmed USA, Inc. · 2018
- This deviceK183173 LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K843696 | Ophthalmic a-Scan a-2000 Sonome | Sonomed Technology, Inc. | 1985 | — |
| −3 | K040668 | E-Z Scan AB5500+ | Sonomed, Inc. | 2004 | — |
| −2 | K140199 | VUPAD | Sonomed, Inc. | 2014 | — |
| −1 | K170761 | LIGHTSonic BUBM | Lightmed USA, Inc. | 2018 | — |
| 0 (this device) | K183173 | LIGHTMED Ultrasound System | Lightmed USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2006 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K170761 | LIGHTSonic BUBMSummary page 4…cular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Other (Specify) Peripheral Peripheral vessel Vessel Other (Specify) N = new indication; P = previously cleared in K170761 haad 6> 013_Minor D2_Section 6-2 System: LIGHTMED Ultrasound System Probe Transducer: 10MHz A-scan Intended… | 2018 |
| † | K140199 | VUPAD | 2014 |
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 34 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
LIGHTMED Ultrasound System is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for measurements inside the ocular structures including orbital, anterior, posterior segment of eye and axial length for determination of IOL Power.
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/K183173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183173: LIGHTMED Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183173
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