510(k) · Cleared
ClearedAlma Lasers Accent B-Shape Massager Handpiece/Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Ltd. · NUV Massager, Vacuum, Light Induced Heating
Cleared on Jan 12, 2009 as substantially equivalent to K080300 (Cutera, Inc., 2008) and 4 other predicates after a 125-day review. Its family tree reaches back 15 generations to 1995. 45 later devices descend from it.
- Decided
- Jan 12, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- NUV
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K943450 (1995). 102 ancestors in all, the oldest K800617 (1980). 45 later devices descend from it, 5 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 1 generation backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- This deviceK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- Descendant · cites it directly · 19 of its ownK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
- Descendant · cites it directly · 18 of its ownK120510 TranscendSyneron Medical, Ltd. · 2013
- Descendant · 2 generations on · 17 of its ownK132431 Thermage CPT SystemSolta Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 14 of its ownK163415 SlimShape SystemSyneron Medical, Ltd. · 2017
- Descendant · 2 generations on · 13 of its ownK170758 Thermage FLX System and AccessoriesSolta Medical · 2017
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 1 generation backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- This deviceK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009 · cites it directly19descendants
- K120510TranscendSyneron Medical, Ltd. · 2013 · cites it directly18descendants
- K132431Thermage CPT SystemSolta Medical, Inc. · 2013 · 2 generations on17descendants
- K163415SlimShape SystemSyneron Medical, Ltd. · 2017 · 2 generations on14descendants
- K170758Thermage FLX System and AccessoriesSolta Medical · 2017 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −1 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| 0 (this device) | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| +1 | K090580 | Thermage Thermacool NXT System and Accessories | Solta Medical, Inc. | 2009 | — |
| +1 | K120510 | Transcend | Syneron Medical, Ltd. | 2013 | — |
| +2 | K132431 | Thermage CPT System | Solta Medical, Inc. | 2013 | 1 |
| +2 | K163415 | SlimShape System | Syneron Medical, Ltd. | 2017 | — |
| +2 | K170758 | Thermage FLX System and Accessories | Solta Medical | 2017 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K080300 | Cutera Multimodal Cellulite Product (Cmmcd)Summary page 1…Module Primary Classification Name(s): Massager, vacuum, light induced heating Ill. Predicate Devices - Cutera Multimodal Cellulite Device (CMMCD) (K080300); ·. Biocellulase, Inc. (aka SmoothShapes & Eleme Medical) SmoothShapes (K05361 1); * Syneron Medical VelaSmooth… | 2008 |
| * | K053611 | SmoothshapesSummary page 1…Ill. Predicate Devices - Cutera Multimodal Cellulite Device (CMMCD) (K080300); ·. Biocellulase, Inc. (aka SmoothShapes & Eleme Medical) SmoothShapes (K05361 1); * Syneron Medical VelaSmooth Shaper (K050397); · Alma Lasers Family of Accent RF Systems [Accent, Accent XL]… | 2006 |
| * | K050397 | Velasmooth, ShaperSummary page 1…llulite Device (CMMCD) (K080300); ·. Biocellulase, Inc. (aka SmoothShapes & Eleme Medical) SmoothShapes (K05361 1); * Syneron Medical VelaSmooth Shaper (K050397); · Alma Lasers Family of Accent RF Systems [Accent, Accent XL] (K072699, K070004). IV. Product Descrip… | 2005 |
| * | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLSummary page 1…& Eleme Medical) SmoothShapes (K05361 1); * Syneron Medical VelaSmooth Shaper (K050397); · Alma Lasers Family of Accent RF Systems [Accent, Accent XL] (K072699, K070004). IV. Product Description The Accent UniForm Massager handpiece/module is a cleanable, reusabl… | 2007 |
| * | K070004 | AccentSummary page 1…thShapes (K05361 1); * Syneron Medical VelaSmooth Shaper (K050397); · Alma Lasers Family of Accent RF Systems [Accent, Accent XL] (K072699, K070004). IV. Product Description The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency… | 2007 |
What descends from it? (45)
See all 455 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 14 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 102 ancestors have a recall of any class.
- Of its descendants, K090580 (Solta Medical, Inc., 2009) has gone furthest, with 19 descendants of its own.
- 1 other device also cites its predicate K080300.
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. 2009, 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 massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
Temporary reduction in the appearance of celuluite.
Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
Temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082622
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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