510(k) · Cleared
ClearedHarmony Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 13, 2015 as substantially equivalent to K072564 (Alma Lasers, Ltd., 2008) and 1 other predicate after a 304-day review. Its family tree reaches back 20 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 13, 2015
- Review
- 304 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K943450 (1995). 515 ancestors in all, the oldest K771218 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- This deviceK141237 Harmony LiteAlma, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK181298 Harmony XL Multi-Application PlatformAlma Lasers, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK230308 Alma HarmonyAlma Lasers, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- This deviceK141237 Harmony LiteAlma, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc. · 2018 · cites it directly3descendants
- K230308Alma HarmonyAlma Lasers, Inc. · 2023 · cites it directly2descendants
- K233024Alma HarmonyAlma Lasers, Inc. · 2024 · 2 generations on1descendant
- K252561BTL-754FFBTL Industries, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −3 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −1 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| 0 (this device) | K141237 | Harmony Lite | Alma, Inc. | 2015 | — |
| +1 | K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | 2018 | — |
| +1 | K230308 | Alma Harmony | Alma Lasers, Inc. | 2023 | — |
| +2 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| +3 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 25 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 30 | 0 |
| 1999 | 26 | 0 |
| 2000 | 34 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 15 | 0 |
| 2007 | 16 | 0 |
| 2008 | 18 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.2 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 5…l Powered Light Instrument, Ultraviolet Dermatological Light, and LED Phototherapy device III. Predicate Devices K072564 Alma Harmony XL Plarform K140009 The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-… | 2008 |
| * | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform Cleared while this submission was under review Summary page 5…atological Light, and LED Phototherapy device III. Predicate Devices K072564 Alma Harmony XL Plarform K140009 The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi- Technology Platforms IV. Product D… | 2014 |
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 20 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 26 of the 515 ancestors have a recall of any class.
- Of its descendants, K181298 (Alma Lasers, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 19 other devices also cite its predicate K072564.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, and aesthetic applications, as follows: 500-600 nm Dye VL Pro Module AFT Hand piece The Advanced Fluorescence Technology (AFT) Dye VL Pro Module handpiece (with and…
Read the full statement (641 words)
The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, and aesthetic applications, as follows:
500-600 nm Dye VL Pro Module AFT Hand piece
The Advanced Fluorescence Technology (AFT) Dye VL Pro Module handpiece (with and without contact-cooling) is indicated for:
•The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and legtelangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• For use on Fitzpatrick skin types I-V.
540-950 nm VP PRO AFT Hand piece
The Advanced Fluorescence Technology (AFT) VP ProModule handpieces (with and without contact-cooling) are indicated for:
•The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),lentigines, nevi, melasma, and cafe-au-lait macules.
•The treatment of cutaneous lesions including warts, scars and striae.
•The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and legtelangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• Use on all skin types (Fitzpatrick I-VI).
570-950 nm SSR Pro Module AFT Hand piece
The Advanced Fluorescence Technology (AFT) 570-950 nm SSR Module handpiece (with and without contact-cooling) is indicated for:
•The treatment of benign pigmented epidermal lesions, including dyschromia , hyperpigmentation, melasma and ephelides (freckles).
•The treatment of face and body vascular and pigmented lesions.
•The treatment of cutaneous lesions, including scars and striae.
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias,rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
•Use on all skin types (Fitzpatrick I-VI).
590 nm LED Module Handpiece
The 590 nm LED module handpiece is indicated to:
• Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain .
• Provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
780-950 nm SHR PRO AFT Module Hand piece
The Advanced Fluorescence Technology (AFT) 780-950 nm SHR PRO (with and without contact-cooling) is indicated for:
•The treatment of pseudofolliculitis barbae (PFB).
•The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hairregrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12months after the completion of the treatment regime.
NIR Large and Small Modules :
The NIR Modules are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscle back pain.
Thermoelectric Cooler (TEC)
The thermoelectric cooler, integrated into the light and laser handpieces, is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• Reduce pain during and/or associated with light or laser treatment;
• Reduce discomfort during and/or associated with light or laser treatment;
•Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during. and/or associated with light orlaser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular orpigmented lesions); and
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular orpigmented lesions).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141237 · printed Nov 3, 2026
Cite this page
510(k) Report. “K141237: Harmony Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K141237
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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