510(k) · Cleared
ClearedResonic Rapid Acoustic Pulse Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeltiq Aesthetics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 1, 2024 as substantially equivalent to K222629 (Zeltiq Aesthetics, Inc., 2022) after a 64-day review. Its family tree reaches back 6 generations to 2009.
- Decided
- Feb 1, 2024
- Review
- 64 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K091537 (2009). No later device cites it as a predicate yet.
- Root · 6 generations backK091537 Cynosure Smartlipo Multiwavelength Laser with 1440NM WavelengthCynosure, Inc. · 2009
- 5 generations backK102541 Cynosure Cellulaze LaserCynosure, Inc. · 2012
- 4 generations backK201801 Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
- 3 generations backK210964 Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
- 2 generations backK212502 Resonic Rapid Acoustic Pulse DeviceSoliton, Inc. · 2021
- 1 generation backK222629 Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc. · 2022
- This deviceK233804 Resonic Rapid Acoustic Pulse DeviceZeltiq Aesthetics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K091537 | Cynosure Smartlipo Multiwavelength Laser with 1440NM Wavelength | Cynosure, Inc. | 2009 | — |
| −5 | K102541 | Cynosure Cellulaze Laser | Cynosure, Inc. | 2012 | — |
| −4 | K201801 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2021 | — |
| −3 | K210964 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | 2021 | — |
| −2 | K212502 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | 2021 | — |
| −1 | K222629 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. | 2022 | — |
| 0 (this device) | K233804 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K222629 | Resonic Rapid Acoustic Pulse DeviceSummary page 4…gy PRODUCT CODE: GEX TM III. PREDICATE DEVICE: Resonic Rapid Acoustic Pulse Device (K222629) IV. DEVICE DESCRIPTION: The Resonic™ Rapid Acoustic Pulse (RAP) device is designed as an accessory to laser treatments to… | 2022 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Resonic™ Rapid Acoustic Pulse device 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 Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to one year of observation. In addition, the Resonic device can improve the appearance of skin laxity in conjunction with improvement in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233804: Resonic Rapid Acoustic Pulse Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233804
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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