510(k) · Cleared
ClearedModified Alma Lasers Family of Accent Radiofrequency (RF) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Jan 21, 2011 as substantially equivalent to K070004 (Alma Lasers, Ltd., 2007) and 2 other predicates after a 273-day review. Its family tree reaches back 16 generations to 1995. 4 later devices descend from it.
- Decided
- Jan 21, 2011
- Review
- 273 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 103 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 2 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 backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 1 generation backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- This deviceK101147 Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK201520 The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK233760 Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK160075 Accent XLAlma Lasers, Inc. · 2016
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 backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 1 generation backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- This deviceK101147 Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012 · cites it directly3descendants
- K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021 · 2 generations on1descendant
- K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024 · 3 generations on0descendants
- K160075Accent XLAlma Lasers, Inc. · 2016 · cites it directly0descendants
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 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −1 | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| 0 (this device) | K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) System | Alma Lasers, Inc. | 2011 | — |
| +1 | K121150 | Alma Lasers Family of Pixel RF Tips | Alma Lasers, Inc. | 2012 | — |
| +2 | K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | 2021 | — |
| +3 | K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | 2024 | — |
| +1 | K160075 | Accent XL | Alma Lasers, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 NUV? 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 NUV device
- #1 K261582 Vacuum Roller RF Slimming Device for Medical…score 16.7 · 17 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 |
|---|---|---|---|
| * | K070004 | AccentSummary page 1…r, vacuum, light induced heating; Electric therapeutic massager 1I1. Predicate Devices " Accent Tm (K070004), cleared 04/23/2007, " Alma Lasers Family of AccentTm Radiofrequency (RF) Systems [Accent, Accent… | 2007 |
| * | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLSummary page 1…" Accent Tm (K070004), cleared 04/23/2007, " Alma Lasers Family of AccentTm Radiofrequency (RF) Systems [Accent, Accent XL] (K072699), cleared 09/19/2007 and " Accent Uniform Massager Handpiece/Module (K082622), cleared 0 1/12/2009. IV. Pr… | 2007 |
| * | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/ModuleSummary page 1…y of AccentTm Radiofrequency (RF) Systems [Accent, Accent XL] (K072699), cleared 09/19/2007 and " Accent Uniform Massager Handpiece/Module (K082622), cleared 0 1/12/2009. IV. Product Description The Alma Lasers Accent Elite system similar to AccentTM RF Sy… | 2009 |
What descends from it? (4)
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 16 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 3 of the 103 ancestors have a recall of any class.
- Of its descendants, K121150 (Alma Lasers, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K070004.
How does its category compare?
All NUV devicesNUV Massager, Vacuum, Light Induced Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NUV
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NUV
99in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUV
No recall names NUV since 2007.
Adverse event reports per year · NUV
1in 2020
MAUDE reports naming product code NUV, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 99 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces. The massage component of the Alma Lasers Accent UniForm Handpiece is intended for use with…
Read the full statement (136 words)
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
The massage component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
* Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
* Temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101147: Modified Alma Lasers Family of Accent Radiofrequency (RF) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101147
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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