# K141237: Harmony Lite

- Pathway: 510(k) (Traditional)
- Applicant: Alma, Inc.
- Decided: Mar 13, 2015 after 304 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 515 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 520 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 5.
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform, Alma Lasers, Ltd. (2014). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K181298: Harmony XL Multi-Application Platform (2018), 3 descendants of its own
- K230308: Alma Harmony (2023), 2 descendants of its own
- K233024: Alma Harmony (2024), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K141237
Methodology: https://510kreport.com/methodology