510(k) · Cleared
ClearedSTOP U Model UXV Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pollogen, Ltd. · PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Cleared on Feb 25, 2021 as substantially equivalent to K182774 (Pollogen, Ltd., 2019) after a 71-day review. Its family tree reaches back 19 generations to 1995. 4 later devices descend from it.
- Decided
- Feb 25, 2021
- Review
- 71 days
- Class
- Class II
- Product code
- PAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K943450 (1995). 93 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK111026 ApolloPollogen, Ltd. · 2011
- 2 generations backK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
- 1 generation backK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- This deviceK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK250341 Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK233766 Geneo X ElitePollogen, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK232424 CurrentBody Skin RFEl Global Trade, Ltd. · 2024
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 6 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 5 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 4 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 3 generations backK111026 ApolloPollogen, Ltd. · 2011
- 2 generations backK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
- 1 generation backK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- This deviceK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K220322Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023 · cites it directly3descendants
- K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · 2026 · 2 generations on0descendants
- K233766Geneo X ElitePollogen, Ltd. · 2024 · 2 generations on0descendants
- K232424CurrentBody Skin RFEl Global Trade, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −6 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −5 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −4 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| −3 | K111026 | Apollo | Pollogen, Ltd. | 2011 | — |
| −2 | K140255 | Stop U (Packed Black Usa); Stop U (Packed White Usa) | Pollogen, Ltd. | 2014 | — |
| −1 | K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | 2019 | — |
| 0 (this device) | K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021 | — |
| +1 | K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023 | — |
| +2 | K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026 | — |
| +2 | K233766 | Geneo X Elite | Pollogen, Ltd. | 2024 | — |
| +2 | K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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 K220322 Pollogen STOP U Model UXV Devicescore 20.0 · 20 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 |
|---|---|---|---|
| * | K182774 | STOP U (Packed Black USA), STOP U (Packed White USA)Summary page 4…Regulation No: 21 C.F.R. §878.4420 Class: II Classification Panel: General & Plastic Surgery Predicate Device: Pollogen Ltd., STOP U (K182774) Intended Use / Indications for Use The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to m… | 2019 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220322 | Pollogen STOP U Model UXV Device | 2023 | 3 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 93 ancestors have a recall of any class.
- Of its descendants, K220322 (Pollogen, Ltd., 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All PAY devicesPAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PAY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAY
165in 2024
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
MAUDE reports naming product code PAY, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 3 | 271 | 0 | 1 |
| 2024 | 3 | 165 | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The STOP U Model UXYV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.
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/K203665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203665: STOP U Model UXV Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203665
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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