510(k) · Cleared
ClearedAccent XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Aug 17, 2016 as substantially equivalent to K091615 (General Project S.R.L., 2010) and 3 other predicates after a 216-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Aug 17, 2016
- Review
- 216 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 19 generations to K943450 (1995). 279 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 2 generations backK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- 1 generation backK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- This deviceK160075 Accent XLAlma Lasers, Inc. · 2016
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 7 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 6 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 5 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 4 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 3 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 2 generations backK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- 1 generation backK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- This deviceK160075 Accent XLAlma Lasers, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −7 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −6 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −5 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −4 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −3 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −2 | K120513 | Glow by Endymed | Endymed Medical, Ltd. | 2012 | — |
| −1 | K121150 | Alma Lasers Family of Pixel RF Tips | Alma Lasers, Inc. | 2012 | — |
| 0 (this device) | K160075 | Accent XL | Alma Lasers, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 21 | 0 |
| 1997 | 23 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 29 | 0 |
| 2003 | 25 | 0 |
| 2004 | 11 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 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 IMI? 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 IMI device
- #1 K240788 Ultrasound Stimulatorscore 10.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K091615 | Med ContourSummary page 5…emarket Notification, Traditional 510(k) 510(k) Summary – Page 1 Accent XL III. Predicate Devices K091615 General Project MC1 (primary) K952536 Zimmer Sono 5 (reference) K121150 Alm… | 2010 |
| * | K121150 | Alma Lasers Family of Pixel RF TipsSummary page 5…XL III. Predicate Devices K091615 General Project MC1 (primary) K952536 Zimmer Sono 5 (reference) K121150 Alma Lasers Family of Pixel RF Tips K101147 Modified Alma Lasers Family of Accent Radiofrequency… | 2012 |
| * | K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemSummary page 3…• Relief of pain • Muscle spasms • Joint contractures • NOT for the treatment of malignancies The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite]. Type of Use (Select one or both, as applicable)… | 2011 |
| * | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/ModuleSummary page 5…) K121150 Alma Lasers Family of Pixel RF Tips K101147 Modified Alma Lasers Family of Accent Radiofrequency (RF) System K082622 Alma Lasers Accent B-Shape Massager Hand piece/Module IV. Product Description The Alma Lasers Accent… | 2009 |
| † | K952536 | SONO 5 | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 11 of the 279 ancestors have a recall of any class.
- 1 other device also cites its predicate K091615.
How does its category compare?
All IMI devicesIMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMI
150in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMI
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMI
2in 2025
MAUDE reports naming product code IMI, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 3 | 150 | 0 | 2 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 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 dermatological 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 hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use…
Read the full statement (235 words)
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatological 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 hand pieces.
The massage component of the Alma Lasers Accent Uniform Hand piece 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.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Ultrasound Module provides ultrasonic diathermy intended for:
• Relief of pain
• Muscle spasms
• Joint contractures
• NOT for the treatment of malignancies
The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160075: Accent XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160075
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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