510(k) · Cleared
Recalled · Class II · 2017Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bios S.R.L. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Nov 19, 2015 as substantially equivalent to K133739 (Cutera, Inc., 2014) and 1 other predicate after a 188-day review. Its family tree reaches back 2 generations to 2012. 9 later devices descend from it. It has been recalled once.
- Decided
- Nov 19, 2015
- Review
- 188 days
- Class
- Class II
- Product code
- PBX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K122389 (2012). 3 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 1 generation backK132949 PellefirmEllman International, Inc. · 2014
- This deviceK151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L. · 2015
- Descendant · cites it directly · 8 of its ownK200359 NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020
- Descendant · 2 generations on · 4 of its ownK210867 NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. · 2021
- Descendant · 3 generations on · 0 of its ownK241733 Hebe (NP0000763)Novasonix Technology S.L. · 2025
- Descendant · 2 generations on · 0 of its ownK240178 RFG-01Zimmer Medizinsysteme GmbH · 2024
- Descendant · 3 generations on · 0 of its ownK230755 NuEra Tight RF Model OptiStreamBios S.R.L. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K200359NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020 · cites it directly8descendants
- K210867NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. · 2021 · 2 generations on4descendants
- K241733Hebe (NP0000763)Novasonix Technology S.L. · 2025 · 3 generations on0descendants
- K240178RFG-01Zimmer Medizinsysteme GmbH · 2024 · 2 generations on0descendants
- K230755NuEra Tight RF Model OptiStreamBios S.R.L. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −1 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| 0 (this device) | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | 2015 | — |
| +1 | K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020 | — |
| +2 | K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021 | — |
| +3 | K241733 | Hebe (NP0000763) | Novasonix Technology S.L. | 2025 | — |
| +2 | K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | 2024 | — |
| +3 | K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 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? (2)
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 |
|---|---|---|---|
| * | K133739 | TrusculptSummary page 4…PBX Legally Marketed Predicate Device (s) 510(k) Number Pro Code Trade Name Applicant K133739 PBX 21 CFR 878.4400 TruSculpt Cutera, Incorporated… | 2014 |
| * | K132949 | PellefirmSummary page 4…TruSculpt Cutera, Incorporated Ellman International, K132949 PBX 21 CFR 878.4400 Pellefirm System… | 2014 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200359 | NuEra Tight, NuEra Tight EMS | 2020 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2017 | Class II | Z-0052-2018 | Software design | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K200359 (Bios S.R.L., 2020) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K133739.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) massage device is intended to provide a temporary reduction in the appearance of cellulite.
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/K151296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151296: Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151296
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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