510(k) · Cleared
ClearedStop U (Packed Black Usa); Stop U (Packed White Usa)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pollogen, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 14, 2014 as substantially equivalent to K111026 (Pollogen, Ltd., 2011) after a 103-day review. Its family tree reaches back 17 generations to 1995. 7 later devices descend from it.
- Decided
- May 14, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 90 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 2 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 1 generation backK111026 ApolloPollogen, Ltd. · 2011
- This deviceK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- Descendant · 2 generations on · 4 of its ownK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK250341 Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK233766 Geneo X ElitePollogen, Ltd. · 2024
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 4 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 3 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 2 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 1 generation backK111026 ApolloPollogen, Ltd. · 2011
- This deviceK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019 · cites it directly5descendants
- K203665STOP U Model UXV DevicePollogen, Ltd. · 2021 · 2 generations on4descendants
- K220322Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023 · 3 generations on3descendants
- K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · 2026 · 4 generations on0descendants
- K233766Geneo X ElitePollogen, Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −4 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −3 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −2 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| −1 | K111026 | Apollo | Pollogen, Ltd. | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021 | — |
| +3 | K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023 | — |
| +4 | K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026 | — |
| +4 | K233766 | Geneo X Elite | Pollogen, 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 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 |
|---|---|---|---|
| * | K111026 | ApolloSummary page 1…C.F.R. §878.4400 Class: 11 Classification Panel: General & Plastic Surgery Predicate Devices Pollogen Ltd., apollo (K1 11026) Device Description The STOPTM U device delivers RF current into the skin to generate heat through electrical im… | 2011 |
What descends from it? (7)
2 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 19 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 3 of the 90 ancestors have a recall of any class.
- Of its descendants, K182774 (Pollogen, Ltd., 2019) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K111026.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
Pollagen's STOP U is intended for use in the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140255
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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