510(k) · Cleared
ClearedMultiple therapy aesthetic treatment device (BHS 202 UNYQUE)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bh Group Us, LLC · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Sep 22, 2026 as substantially equivalent to K202780 (Neauvia North America, 2021) and 1 other predicate after a 715-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Sep 22, 2026
- Review
- 715 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K943450 (1995). 314 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 2 generations backK142093 V20 SystemViora, Ltd. · 2014
- 1 generation backK150035 V10 systemViora, Ltd. · 2015
- This deviceK243223 Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC · 2026
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 7 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 6 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 5 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 4 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 3 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 2 generations backK142093 V20 SystemViora, Ltd. · 2014
- 1 generation backK150035 V10 systemViora, Ltd. · 2015
- This deviceK243223 Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −7 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −6 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −5 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −4 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −3 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −2 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −1 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| 0 (this device) | K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 15 | 0 |
| 1995 | 15 | 0 |
| 1996 | 20 | 0 |
| 1997 | 23 | 0 |
| 1998 | 21 | 0 |
| 1999 | 12 | 0 |
| 2000 | 25 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 23 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K202780 | SectumSummary page 5…878.4400 Product Code(s) PBX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202780 Sectum System PBX K150035 V10 system(V-ST Handpiece) PBX Device Description Summary 21 CFR 807.92(a)(4) The system includes a ma… | 2021 |
| * | K150035 | V10 systemSummary page 5…PBX | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K202780 Sectum System PBX K150035 V10 system(V-ST Handpiece) PBX Device Description Summary 21 CFR 807.92(a)(4) The system includes a main control console and one… | 2015 |
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 31 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 11 of the 314 ancestors have a recall of any class.
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. 2026, 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 multi-therapy aesthetic treatment device is designed to apply cold and radiofrequency.
Radiofrequency hand piece raises tissue temperature to treat specific medical conditions, including
relieving pain, relieving muscle spasms, improving local blood circulation, and temporarily improving
the appearance of cellulite.
The multi-therapy aesthetic treatment device is intended for prescription use only, as defined in 21
CFR 801 Subpart D.
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/K243223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243223: Multiple therapy aesthetic treatment device (BHS 202 UNYQUE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243223
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026