510(k) · Cleared
ClearedBeShape One™ Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beshape Technologies, Ltd. · OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Cleared on Sep 29, 2023 as substantially equivalent to K181896 (Jeisys Medical, Inc., 2019) after a 116-day review. Its family tree reaches back 4 generations to 2009.
- Decided
- Sep 29, 2023
- Review
- 116 days
- Class
- Class II
- Product code
- OHV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN080006 (2009). No later device cites it as a predicate yet.
- Root · 4 generations backDEN080006 Ulthera System, Model 8850-0001Ulthera, Inc. · 2009
- 3 generations backK100874 Liposonix System, Model 1 P00XXXXMedicis Technologies Corporation · 2011
- 2 generations backK112626 Lipsonix (R) System Model 2Medicis Technologies Corporation · 2011
- 1 generation backK181896 LIPOcelJeisys Medical, Inc. · 2019
- This deviceK231628 BeShape One™ DeviceBeshape Technologies, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN080006 | Ulthera System, Model 8850-0001 | Ulthera, Inc. | 2009 | — |
| −3 | K100874 | Liposonix System, Model 1 P00XXXX | Medicis Technologies Corporation | 2011 | — |
| −2 | K112626 | Lipsonix (R) System Model 2 | Medicis Technologies Corporation | 2011 | — |
| −1 | K181896 | LIPOcel | Jeisys Medical, Inc. | 2019 | — |
| 0 (this device) | K231628 | BeShape One™ Device | Beshape Technologies, Ltd. | 2023 | — |
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 OHV? 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 OHV device
- #1 K250418 Ulthera System (UC-1 Control Unit PRIME Model…score 14.1 · 7 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 |
|---|---|---|---|
| * | K181896 | LIPOcelSummary page 5…e Device: = The BeShape One device is substantially equivalent to the following FDA-cleared predicate device: Manufacturer Device 510(k) No. Jeisys Medical Inc. LIPOcel K181896 181 BeShape One System 510(k) K231628 Section 5 — 510(k) Summary Device Description: The BeShape One™ device i… | 2019 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All OHV devicesOHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OHV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHV
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHV
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHV
20in 2025
MAUDE reports naming product code OHV, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 18 |
| 2014 | 3 | 171 | 0 | 17 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 3 | 107 | 0 | 29 |
| 2017 | 1 | — | 0 | 29 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 11 |
| 2022 | 1 | — | 0 | 12 |
| 2023 | 7 | 90 | 1 | 11 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 2 | — | 0 | 20 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BeShape One™ device delivers High Intensity, Non-Focused Ultrasound energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.
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/K231628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231628: BeShape One™ Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231628
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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