510(k) · Cleared
ClearedPollogen STOP 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 May 4, 2023 as substantially equivalent to K203665 (Pollogen, Ltd., 2021) after a 455-day review. Its family tree reaches back 20 generations to 1995. 3 later devices descend from it.
- Decided
- May 4, 2023
- Review
- 455 days
- Class
- Class II
- Product code
- PAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K943450 (1995). 94 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
- 2 generations backK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- 1 generation backK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
- This deviceK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250341 Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233766 Geneo X ElitePollogen, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232424 CurrentBody Skin RFEl Global Trade, Ltd. · 2024
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 backK070004 AccentAlma Lasers, Ltd. · 2007
- 6 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 5 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 4 generations backK111026 ApolloPollogen, Ltd. · 2011
- 3 generations backK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
- 2 generations backK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- 1 generation backK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
- This deviceK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView 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 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −6 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −5 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| −4 | K111026 | Apollo | Pollogen, Ltd. | 2011 | — |
| −3 | K140255 | Stop U (Packed Black Usa); Stop U (Packed White Usa) | Pollogen, Ltd. | 2014 | — |
| −2 | K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | 2019 | — |
| −1 | K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021 | — |
| 0 (this device) | K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023 | — |
| +1 | K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026 | — |
| +1 | K233766 | Geneo X Elite | Pollogen, Ltd. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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 K250341 Sensilift Pro (ST300XXYYZZZ)score 16.6 · 21 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 |
|---|---|---|---|
| * | K203665 | STOP U Model UXV DeviceSummary page 4…. §878.4420 Class: II Classification Panel: General & Plastic Surgery Predicate Device: Pollogen Ltd., STOP U Model UXV (K203665) Intended Use / Indications for Use The STOP U Model UXV device is intended for use in the non-invasive treatment o… | 2021 |
| † | K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | 2019 |
| † | K140255 | Stop U (Packed Black Usa); Stop U (Packed White Usa) | 2014 |
What descends from it? (3)
3 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 28 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 94 ancestors have a recall of any class.
- Of its descendants, K250341 (El Global Trade, Ltd., 2026) has gone furthest, with 0 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. 2023, 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 UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220322: Pollogen 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/K220322
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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