510(k) · Cleared
ClearedRapid Acoustic Pulse 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 Jan 29, 2021 as substantially equivalent to K102541 (Cynosure, Inc., 2012) after a 213-day review. Its family tree reaches back 2 generations to 2009. 12 later devices descend from it.
- Decided
- Jan 29, 2021
- Review
- 213 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K091537 (2009). 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK091537 Cynosure Smartlipo Multiwavelength Laser with 1440NM WavelengthCynosure, Inc. · 2009
- 1 generation backK102541 Cynosure Cellulaze LaserCynosure, Inc. · 2012
- This deviceK201801 Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
- Descendant · cites it directly · 7 of its ownK223237 SofWave SystemSofwave Medical, Ltd. · 2022
- Descendant · 2 generations on · 6 of its ownK230019 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 3 generations on · 5 of its ownK230820 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 4 generations on · 4 of its ownK232455 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 5 generations on · 3 of its ownK240687 SofWave SystemSofwave Medical, Ltd. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K223237SofWave SystemSofwave Medical, Ltd. · 2022 · cites it directly7descendants
- K230019SofWave SystemSofwave Medical, Ltd. · 2023 · 2 generations on6descendants
- K230820SofWave SystemSofwave Medical, Ltd. · 2023 · 3 generations on5descendants
- K232455SofWave SystemSofwave Medical, Ltd. · 2023 · 4 generations on4descendants
- K240687SofWave SystemSofwave Medical, Ltd. · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K091537 | Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength | Cynosure, Inc. | 2009 | — |
| −1 | K102541 | Cynosure Cellulaze Laser | Cynosure, Inc. | 2012 | — |
| 0 (this device) | K201801 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2021 | — |
| +1 | K223237 | SofWave System | Sofwave Medical, Ltd. | 2022 | — |
| +2 | K230019 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +3 | K230820 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +4 | K232455 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +5 | K240687 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223237 (Sofwave Medical, Ltd., 2022) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K102541.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The RAP device is also indicated for short-term improvement in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201801 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201801: Rapid Acoustic Pulse Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201801
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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