510(k) · Cleared
ClearedAccent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 23, 2007 as substantially equivalent to K051214 (Lumenis, Inc., 2005) and 5 other predicates after a 110-day review. Its family tree reaches back 13 generations to 1995. 181 later devices descend from it.
- Decided
- Apr 23, 2007
- Review
- 110 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K943450 (1995). 86 ancestors in all, the oldest K800617 (1980). 181 later devices descend from it, 12 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- This deviceK070004 AccentAlma Lasers, Ltd. · 2007
- Descendant · cites it directly · 101 of its ownK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- Descendant · cites it directly · 84 of its ownK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- Descendant · 2 generations on · 64 of its ownK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · 2 generations on · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · cites it directly · 53 of its ownK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 1 generation backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- This deviceK070004 AccentAlma Lasers, Ltd. · 2007
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 181 · See all- K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009 · cites it directly101descendants
- K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd. · 2007 · cites it directly84descendants
- K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011 · 2 generations on64descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · 2 generations on57descendants
- K101967Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010 · cites it directly53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −8 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −7 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −6 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −5 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −1 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| 0 (this device) | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| +1 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| +1 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| +2 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +2 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +1 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 15 | 0 |
| 2024 | 26 | 0 |
| 2025 | 24 | 0 |
| 2026 | 15 | 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? (6)
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 |
|---|---|---|---|
| * | K051214 | Aluma Skin Renewal SystemSummary page 1…& Coagulation Device & Accessories III. Predicate Devices * Lumenis Aluma Skin Renewal System (K051214) * Syneron Medical Polaris WR (K031671) * Thermage ThermaCool TC (K053365, K040135, and K033942) * The… | 2005 |
| * | K031671 | Polaris WRSummary page 1…Accessories III. Predicate Devices * Lumenis Aluma Skin Renewal System (K051214) * Syneron Medical Polaris WR (K031671) * Thermage ThermaCool TC (K053365, K040135, and K033942) * ThermageThermaCoolIIA (KO13034) IV. Product… | 2003 |
| * | K053365 | Modification to Thermage Thermacool SystemSummary page 1…ies III. Predicate Devices * Lumenis Aluma Skin Renewal System (K051214) * Syneron Medical Polaris WR (K031671) * Thermage ThermaCool TC (K053365, K040135, and K033942) * ThermageThermaCoolIIA (KO13034) IV. Product Description The Alma Lasers Accent… | 2005 |
| * | K040135 | Thermage Thermacool SystemSummary page 1…Predicate Devices * Lumenis Aluma Skin Renewal System (K051214) * Syneron Medical Polaris WR (K031671) * Thermage ThermaCool TC (K053365, K040135, and K033942) * ThermageThermaCoolIIA (KO13034) IV. Product Description The Alma Lasers AccentTM device… | 2004 |
| * | K033942 | Thermage Thermacool SystemSummary page 1…e Devices * Lumenis Aluma Skin Renewal System (K051214) * Syneron Medical Polaris WR (K031671) * Thermage ThermaCool TC (K053365, K040135, and K033942) * ThermageThermaCoolIIA (KO13034) IV. Product Description The Alma Lasers AccentTM device is comprised… | 2004 |
| * | K013034 | Modification to: Thermacool Iia | 2001 |
What descends from it? (181)
See all 18112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083461 | Imagine TC Skin Therapy System | 2009 | 101 |
| K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL | 2007 | 84 |
| K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | 2010 | 53 |
| K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | 2009 | 45 |
| K090025 | Matrix RF Applicator | 2010 | 18 |
| K132431 | Thermage CPT System | 2013 | 17 |
| K083590 | Iskra Medical Green Irf Prestige | 2009 | 13 |
| K092191 | Exilis, Model 5000 | 2009 | 12 |
| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) System | 2011 | 4 |
| K121150 | Alma Lasers Family of Pixel RF Tips | 2012 | 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 12 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 86 ancestors have a recall of any class.
- Of its descendants, K083461 (Endymion Medical, Ltd., 2009) has gone furthest, with 101 descendants of its own.
- 6 other devices also cite its predicate K051214.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 AccentTM device is intended for use in dermatologic and general surgical procedures.
The AccentTM device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070004: Accent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070004
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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