510(k) · Cleared
ClearedAluma Skin Renewal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 24, 2005 as substantially equivalent to K033942 (Thermage, Inc., 2004) and 2 other predicates after a 165-day review. Its family tree reaches back 12 generations to 1995. 476 later devices descend from it.
- Decided
- Oct 24, 2005
- Review
- 165 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K943450 (1995). 84 ancestors in all, the oldest K800617 (1980). 476 later devices descend from it, 7 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- This deviceK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · cites it directly · 297 of its ownK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · cites it directly · 181 of its ownK070004 AccentAlma Lasers, Ltd. · 2007
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 4 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- This deviceK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
Showing 5 of 476 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 476 · See all- K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006 · cites it directly297descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
- K070004AccentAlma Lasers, Ltd. · 2007 · cites it directly181descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −4 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −1 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| 0 (this device) | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +1 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +1 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 9 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 9 | 0 |
| 2014 | 20 | 0 |
| 2015 | 16 | 0 |
| 2016 | 28 | 0 |
| 2017 | 27 | 0 |
| 2018 | 27 | 0 |
| 2019 | 17 | 0 |
| 2020 | 31 | 0 |
| 2021 | 27 | 0 |
| 2022 | 43 | 0 |
| 2023 | 37 | 0 |
| 2024 | 58 | 0 |
| 2025 | 56 | 0 |
| 2026 | 38 | 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? (3)
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 |
|---|---|---|---|
| * | K033942 | Thermage Thermacool SystemSummary page 1…78.4400). Legally Marketed Predicate Devices: Thermage, Inc ThermaCoolTm TC System (K(033942 and K(040135) Syneron Medical Ltd.,… | 2004 |
| * | K040135 | Thermage Thermacool SystemSummary page 1…Thermage, Inc ThermaCoolTm TC System (K(033942 and K(040135) Syneron Medical Ltd., PolarisTM (K(031671)… | 2004 |
| * | K031671 | Polaris WRSummary page 1…K(040135) Syneron Medical Ltd., PolarisTM (K(031671) 21 System Description: The Aluma Skin Renewal System is a… | 2003 |
What descends from it? (476)
See all 4767 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 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 3 of the 84 ancestors have a recall of any class.
- Of its descendants, K060448 (Lumenis, Ltd., 2006) has gone furthest, with 297 descendants of its own.
- 7 other devices also cite its predicate K033942.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and rhytids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051214: Aluma Skin Renewal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051214
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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