510(k) Report

510(k) · Cleared

Cleared

CurrentBody Skin RF

K232424510(k) TraditionalCleared Mar 6, 2024208-day reviewClass II21 CFR 878.4420

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

El Global Trade, Ltd. · PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Cleared on Mar 6, 2024 as substantially equivalent to K220322 (Pollogen, Ltd., 2023) after a 208-day review. Its family tree reaches back 21 generations to 1995.

Decided
Mar 6, 2024
Review
208 days
Class
Class II
Product code
PAY
Recalls
None
Predicates
1

Its longest line of descent runs back 21 generations to K943450 (1995). 95 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2005: 1 other ancestor2004: 2 other ancestors2003: 3 other ancestors2002: 8 other ancestors2001: 5 other ancestors2000: 8 other ancestors1998: 6 other ancestors1997: 13 other ancestors1996: 10 other ancestors1999: 4 other ancestors1995: 4 other ancestors1994: 2 other ancestors1990: 1 other ancestor1992: 3 other ancestors1980: 1 other ancestor1993: 1 other ancestor1985: 1 other ancestorK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K070004 · Accent · Alma Lasers, Ltd. · 2007K083461 · Imagine TC Skin Therapy System · Endymion Medical, Ltd. · 2009K100586 · Venus Freeze System · Venus Concept, Ltd. · 2010K111026 · Apollo · Pollogen, Ltd. · 2011K140255 · Stop U (Packed Black Usa); Stop U (Packed White Usa) · Pollogen, Ltd. · 2014K182774 · STOP U (Packed Black USA), STOP U (Packed White USA) · Pollogen, Ltd. · 2019K203665 · STOP U Model UXV Device · Pollogen, Ltd. · 2021K220322 · Pollogen STOP U Model UXV Device · Pollogen, Ltd. · 202319801990200020102020
Other ancestors, by generation 4 generations back: 1 other ancestor7 generations back: 1 other ancestor8 generations back: 4 other ancestors9 generations back: 19 other ancestors10 generations back: 18 other ancestors11 generations back: 13 other ancestors12 generations back: 15 other ancestors13 generations back: 3 other ancestors K220322 · Pollogen STOP U Model UXV Device · Pollogen, Ltd. · 2023K203665 · STOP U Model UXV Device · Pollogen, Ltd. · 2021K182774 · STOP U (Packed Black USA), STOP U (Packed White USA) · Pollogen, Ltd. · 2019K140255 · Stop U (Packed Black Usa); Stop U (Packed White Usa) · Pollogen, Ltd. · 2014K111026 · Apollo · Pollogen, Ltd. · 2011K100586 · Venus Freeze System · Venus Concept, Ltd. · 2010K083461 · Imagine TC Skin Therapy System · Endymion Medical, Ltd. · 2009K070004 · Accent · Alma Lasers, Ltd. · 2007K051214 · Aluma Skin Renewal System · Lumenis, Inc. · 2005K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−20−15−10−50
  1. Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 17 generations between
  3. 3 generations backK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
  4. 2 generations backK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
  5. 1 generation backK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
  6. This deviceK232424 CurrentBody Skin RFEl Global Trade, Ltd. · 2024
Show all 21 generations
  1. Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 9 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
  14. 8 generations backK070004 AccentAlma Lasers, Ltd. · 2007
  15. 7 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
  16. 6 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
  17. 5 generations backK111026 ApolloPollogen, Ltd. · 2011
  18. 4 generations backK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
  19. 3 generations backK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
  20. 2 generations backK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
  21. 1 generation backK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
  22. This deviceK232424 CurrentBody Skin RFEl Global Trade, Ltd. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−20K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−19K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−18K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−17K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−16K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−15K000944Thermage Thermacool SystemThermage, Inc.2000—
−14K013034Modification to: Thermacool IiaThermage, Inc.2001—
−13K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−12K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−11K030142Thermacool TC SystemThermage, Inc.2003—
−10K031671Polaris WRSyneron Medical, Ltd.2003—
−9K051214Aluma Skin Renewal SystemLumenis, Inc.2005—
−8K070004AccentAlma Lasers, Ltd.2007—
−7K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009—
−6K100586Venus Freeze SystemVenus Concept, Ltd.2010—
−5K111026ApolloPollogen, Ltd.2011—
−4K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.2014—
−3K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.2019—
−2K203665STOP U Model UXV DevicePollogen, Ltd.2021—
−1K220322Pollogen STOP U Model UXV DevicePollogen, Ltd.2023—
0 (this device)K232424CurrentBody Skin RFEl Global Trade, Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199010
199230
199310
199420
199540
1996100
1997130
199860
199940
200080
200150
200280
200330
200420
200510
201510
FIG. 1 — Lineage of K232424, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 PAY? 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 PAY device

  1. #1 K220322 Pollogen STOP U Model UXV Devicescore 20.0 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K220322Pollogen STOP U Model UXV Device
Summary page 4
…rentBody Skin RF device is substantially equivalent to the following Predicate Device: Pollogen Stop U Model UXV device, cleared under 510(k) number K220322 on May 4th, 2023. 5. DEVICE DESCRIPTION Page 1…
Pollogen, Ltd.2023—

Also cleared against K220322: 2 other devices →

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 29 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
  • 3 of the 95 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K220322.

How does its category compare?

All PAY devices

PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · PAY

1in 2025

2015: 12017: 12019: 12021: 12023: 32024: 32025: 12026 (partial year): 1
2007high 3 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAY

165in 2024

2023: 271 days median2024: 165 days median
2007high 271 (2023) · low 165 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PAY

No recall names PAY since 2007.

Adverse event reports per year · PAY

2in 2025

2022: 22023: 12025: 2
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code PAY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20171—00
20180—00
20191—00
20200—00
20211—00
20220—02
2023327101
2024316500
20251—02
20261—0—

What is it indicated for?

The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K232424: CurrentBody Skin RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232424

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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