510(k) · Cleared
ClearedAlma Lasers Family of Pixel RF Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 21, 2012 as substantially equivalent to K072699 (Alma Lasers, Ltd., 2007) and 7 other predicates after a 158-day review. Its family tree reaches back 18 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 21, 2012
- Review
- 158 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 18 generations to K943450 (1995). 273 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 1 generation backK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- This deviceK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK201520 The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021
- Descendant · 2 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 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 6 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 5 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 4 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 1 generation backK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- This deviceK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021 · cites it directly1descendant
- K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024 · 2 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 |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −6 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −5 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −4 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −3 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −2 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −1 | K120513 | Glow by Endymed | Endymed Medical, Ltd. | 2012 | — |
| 0 (this device) | K121150 | Alma Lasers Family of Pixel RF Tips | Alma Lasers, Inc. | 2012 | — |
| +1 | K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | 2021 | — |
| +2 | 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 |
| 1982 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 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 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 29 | 0 |
| 2003 | 24 | 0 |
| 2004 | 11 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (8)
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 |
|---|---|---|---|
| * | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLSummary page 1…surgical cutting and coagulation device and accessories 111. Predicate Devices * Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083… | 2007 |
| * | K070004 | AccentSummary page 1…cutting and coagulation device and accessories 111. Predicate Devices * Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083461, K101… | 2007 |
| * | K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) System | 2011 |
| * | K073572 | Matrix RF ApplicatorSummary page 1…ices * Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083461, K101510, K120513) Premarket Notification, Special 510(k) Submission for:… | 2008 |
| * | K090025 | Matrix RF ApplicatorSummary page 1…Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083461, K101510, K120513) Premarket Notification, Special 510(k) Submission for:… | 2010 |
| * | K083461 | Imagine TC Skin Therapy SystemSummary page 1…s [Accent, Accent XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083461, K101510, K120513) Premarket Notification, Special 510(k) Submission for: Section 5: Page I Alma Lasers… | 2009 |
| * | K101510 | Fractional Skin Resurfacing (FSR) ApplicatorSummary page 1…, Accent XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083461, K101510, K120513) Premarket Notification, Special 510(k) Submission for: Section 5: Page I Alma Lasers Accent Pi… | 2011 |
| * | K120513 | Glow by Endymed Cleared while this submission was under review Summary page 1…XL, Accent Elite] (K072699, K070004, KIOI 147) * Syneron Medical Matrix REF Applicator (K0735 72, K090025) * EndyMed R-E Applicator (K083461, K101510, K120513) Premarket Notification, Special 510(k) Submission for: Section 5: Page I Alma Lasers Accent Pixel RTips… | 2012 |
What descends from it? (3)
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 17 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 10 of the 273 ancestors have a recall of any class.
- Of its descendants, K201520 (Alma Lasers, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K072699.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic add general surgical procedures.
The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RE Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121150: Alma Lasers Family of Pixel RF Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121150
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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