510(k) · Cleared
ClearedApollo
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 Nov 16, 2011 as substantially equivalent to K100586 (Venus Concept, Ltd., 2010) and 1 other predicate after a 217-day review. Its family tree reaches back 16 generations to 1995. 14 later devices descend from it.
- Decided
- Nov 16, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K943450 (1995). 89 ancestors in all, the oldest K800617 (1980). 14 later devices descend from it, 3 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 2 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 1 generation backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- This deviceK111026 ApolloPollogen, Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK140255 Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014
- Descendant · 2 generations on · 5 of its ownK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- Descendant · 3 generations on · 4 of its ownK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK171359 Pollogen Legend+ SystemPollogen, Ltd. · 2017
- Descendant · 4 generations on · 3 of its ownK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 3 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 2 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 1 generation backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- This deviceK111026 ApolloPollogen, Ltd. · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd. · 2014 · cites it directly7descendants
- K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019 · 2 generations on5descendants
- K203665STOP U Model UXV DevicePollogen, Ltd. · 2021 · 3 generations on4descendants
- K171359Pollogen Legend+ SystemPollogen, Ltd. · 2017 · cites it directly4descendants
- K220322Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −3 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −2 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −1 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| 0 (this device) | K111026 | Apollo | Pollogen, Ltd. | 2011 | — |
| +1 | 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 | — |
| +3 | K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021 | — |
| +1 | K171359 | Pollogen Legend+ System | Pollogen, Ltd. | 2017 | — |
| +4 | K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K100586 | Venus Freeze SystemSummary page 2…e following predicate devices is claimed: - Device Name 510k No Date of Clearance Venus Concept Ltd. Venus K100586 Nov 29, 2010 Freeze ____________________ EndyMed Imagine TC Skin… | 2010 |
| * | K083461 | Imagine TC Skin Therapy SystemSummary page 2…ept Ltd. Venus K100586 Nov 29, 2010 Freeze ____________________ EndyMed Imagine TC Skin K(083461 Jul 24, 2009 Treatment System ____ ____________ Per-formance Standards… | 2009 |
What descends from it? (14)
See all 143 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 16 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 3 of the 89 ancestors have a recall of any class.
- Of its descendants, K140255 (Pollogen, Ltd., 2014) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K100586.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The apollo is a non-invasive device intended for use in Dermatologic and General Surgical procedures for 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/K111026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111026: Apollo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111026
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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