510(k) · Cleared
ClearedNuEra Tight RF, NuEra Tight RF Plus
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 Apr 21, 2021 as substantially equivalent to K200359 (Bios S.R.L., 2020) after a 29-day review. Its family tree reaches back 4 generations to 2012. 4 later devices descend from it.
- Decided
- Apr 21, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K122389 (2012). 5 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 3 generations backK132949 PellefirmEllman International, Inc. · 2014
- 2 generations backK151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L. · 2015 · Recalled
- 1 generation backK200359 NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020
- This deviceK210867 NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. · 2021
- Descendant · cites it directly · 0 of its ownK241733 Hebe (NP0000763)Novasonix Technology S.L. · 2025
- Descendant · cites it directly · 0 of its ownK230755 NuEra Tight RF Model OptiStreamBios S.R.L. · 2023
- Descendant · cites it directly · 0 of its ownK223856 NuEra Tight RF FamilyBios S.R.L. · 2023
- Descendant · cites it directly · 0 of its ownK223907 NuEra Tight RF Model APMD145.M70-USBios S.R.L. · 2023
Most influential descendants
Showing 4 of 4 · See all- K241733Hebe (NP0000763)Novasonix Technology S.L. · 2025 · cites it directly0descendants
- K230755NuEra Tight RF Model OptiStreamBios S.R.L. · 2023 · cites it directly0descendants
- K223856NuEra Tight RF FamilyBios S.R.L. · 2023 · cites it directly0descendants
- K223907NuEra Tight RF Model APMD145.M70-USBios S.R.L. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −3 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −2 | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | 2015 | 1 |
| −1 | K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020 | — |
| 0 (this device) | K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021 | — |
| +1 | K241733 | Hebe (NP0000763) | Novasonix Technology S.L. | 2025 | — |
| +1 | K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023 | — |
| +1 | K223856 | NuEra Tight RF Family | Bios S.R.L. | 2023 | — |
| +1 | K223907 | NuEra Tight RF Model APMD145.M70-US | 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 |
|---|---|---|
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | K200359 | NuEra Tight, NuEra Tight EMSSummary page 4…frequency induced heat Predicate and Reference Devices 510(k) Ref Pro Code/Reg No Trade Name Applicant Predicate Device |K200359 PBX, 878.4400 NuEra Tight RF Family Bios s.r.l. Device Description NuEra Tight RF Family… | 2020 |
What descends from it? (4)
4 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 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K241733 (Novasonix Technology S.L., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K200359.
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. 2021, 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 NuEra Tight RF Family is intended for:
to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
to provide, with a massage device, 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/K210867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210867: NuEra Tight RF, NuEra Tight RF Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210867
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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