510(k) · Cleared
ClearedNuEra Tight, NuEra Tight EMS
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 Aug 11, 2020 as substantially equivalent to K151296 (Bios S.R.L., 2015) after a 180-day review. Its family tree reaches back 3 generations to 2012. 8 later devices descend from it.
- Decided
- Aug 11, 2020
- Review
- 180 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122389 (2012). 4 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 2 generations backK132949 PellefirmEllman International, Inc. · 2014
- 1 generation backK151296 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L. · 2015 · Recalled
- This deviceK200359 NuEra Tight, NuEra Tight EMSBios S.R.L. · 2020
- Descendant · cites it directly · 4 of its ownK210867 NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. · 2021
- Descendant · 2 generations on · 0 of its ownK241733 Hebe (NP0000763)Novasonix Technology S.L. · 2025
- Descendant · cites it directly · 0 of its ownK240178 RFG-01Zimmer Medizinsysteme GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK230755 NuEra Tight RF Model OptiStreamBios S.R.L. · 2023
- Descendant · 2 generations on · 0 of its ownK223856 NuEra Tight RF FamilyBios S.R.L. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210867NuEra Tight RF, NuEra Tight RF PlusBios S.R.L. · 2021 · cites it directly4descendants
- K241733Hebe (NP0000763)Novasonix Technology S.L. · 2025 · 2 generations on0descendants
- K240178RFG-01Zimmer Medizinsysteme GmbH · 2024 · cites it directly0descendants
- K230755NuEra Tight RF Model OptiStreamBios S.R.L. · 2023 · 2 generations on0descendants
- K223856NuEra Tight RF FamilyBios S.R.L. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −2 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −1 | K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.R.L. | 2015 | 1 |
| 0 (this device) | K200359 | NuEra Tight, NuEra Tight EMS | Bios S.R.L. | 2020 | — |
| +1 | K210867 | NuEra Tight RF, NuEra Tight RF Plus | Bios S.R.L. | 2021 | — |
| +2 | K241733 | Hebe (NP0000763) | Novasonix Technology S.L. | 2025 | — |
| +1 | K240178 | RFG-01 | Zimmer Medizinsysteme GmbH | 2024 | — |
| +2 | K230755 | NuEra Tight RF Model OptiStream | Bios S.R.L. | 2023 | — |
| +2 | K223856 | NuEra Tight RF Family | 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 |
|---|---|---|
| 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? (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? (8)
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 8 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K210867 (Bios S.R.L., 2021) has gone furthest, with 4 descendants of its own.
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. 2020, 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 as stated in the FDA summary.
https://510kreport.com/device/K200359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200359: NuEra Tight, NuEra Tight EMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200359
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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