510(k) · Cleared
ClearedSoliton Acoustic Wave Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soliton, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 24, 2019 as substantially equivalent to K150212 (On Light Sciences, Inc., 2015) after an 81-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- May 24, 2019
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950019 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 1 generation backK150212 DeScribe Transparent PFD PatchOn Light Sciences, Inc. · 2015
- This deviceK190542 Soliton Acoustic Wave DeviceSoliton, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200331 Rapid Acoustic Pulse DeviceSoliton, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200331Rapid Acoustic Pulse DeviceSoliton, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −1 | K150212 | DeScribe Transparent PFD Patch | On Light Sciences, Inc. | 2015 | — |
| 0 (this device) | K190542 | Soliton Acoustic Wave Device | Soliton, Inc. | 2019 | — |
| +1 | K200331 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K150212 | DeScribe Transparent PFD PatchSummary page 4…and plastic surgery and in dermatology (21 CFR 878.4810) Predicate Device: ON Light Science’s DeScribe® Transparent PFD Patch (K150212) Device Description The Soliton Acoustic Wave Device (AWD) is designed as an accessory to laser treatments for ta… | 2015 |
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 |
|---|---|---|---|
| K200331 | Rapid Acoustic Pulse Device | 2020 | 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 24 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200331 (Soliton, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150212.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Soliton Acoustic Wave Device (AWD) is indicated for use as as an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190542: Soliton Acoustic Wave Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190542
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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