510(k) · Cleared
ClearedLIGHTSonic BUBM
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 Apr 13, 2018 as substantially equivalent to K140199 (Sonomed, Inc., 2014) after a 396-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- Apr 13, 2018
- Review
- 396 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K843696 (1985). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK843696 Ophthalmic a-Scan a-2000 SonomeSonomed Technology, Inc. · 1985
- 2 generations backK040668 E-Z Scan AB5500+Sonomed, Inc. · 2004
- 1 generation backK140199 VUPADSonomed, Inc. · 2014
- This deviceK170761 LIGHTSonic BUBMLightmed USA, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK183173 LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183173LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K843696 | Ophthalmic a-Scan a-2000 Sonome | Sonomed Technology, Inc. | 1985 | — |
| −2 | K040668 | E-Z Scan AB5500+ | Sonomed, Inc. | 2004 | — |
| −1 | K140199 | VUPAD | Sonomed, Inc. | 2014 | — |
| 0 (this device) | K170761 | LIGHTSonic BUBM | Lightmed USA, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K140199 | VUPADSummary page 4…: 892.1560, 892.1570 Product code: IYO, ITX III. PREDICATE DEVICE Substantial equivalence to the following predicate device is as follows: Sonomen Inc. Vupad K140199 Decision Date:04/01/2014 IV. DEVICE DESCRIPTION The LIGHTMED Ultrasound System is a portable ultrasound b… | 2014 |
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 |
|---|---|---|---|
| K183173 | LIGHTMED Ultrasound System | 2019 | 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?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K183173 (Lightmed USA, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140199.
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. 2018, 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?
LIGHTSonic B∣UBM is a non-invasion diagnostic ophthalmic ultrasound instrument specifically designed for
measurements inside the ocular structures including orbital, anterior and posterior segment of eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170761: LIGHTSonic BUBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170761
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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