HARMONY LITE

K141237 · Alma, Inc. · ONF · Mar 13, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K141237
• Device Name: HARMONY LITE
• Applicant: Alma, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Mar 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation) 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, 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, 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, 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 contactcooling) is indicated for: •The treatment of pseudofolliculitis barbae (PFB). •The removal of unwanted hair and to effect stable long-term or permanent hair 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 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 or pigmented lesions).

Device Story

Multi-application platform utilizing various handpieces (IPL, LED, NIR) for dermatologic and surgical procedures; console includes touch-screen, power supply, and cooling system. Handpieces deliver light/infrared energy to target tissue via photothermolysis or topical heating. Operated by clinicians in medical settings. Integrated thermoelectric cooling (TEC) protects epidermis, reduces pain, and allows higher fluences. Output affects tissue via thermal energy; clinical benefit includes lesion removal, hair reduction, and pain relief. System uses footswitch control.

Clinical Evidence

No human clinical trials provided. Evidence includes bench testing (IEC 60601-1, 60601-1-2, 60601-2-57) and collateral animal data (pig study) comparing Dye VL Pro IPL to pulsed dye laser (PDL) data, supported by Monte Carlo simulations of energy absorption and penetration depth.

Technological Characteristics

Platform uses IPL (AFT), LED, and NIR modules. Materials: Quartz tubes for NIR. Energy: Light (500-950nm) and IR (1300nm). Cooling: Integrated thermoelectric cooler (TEC). Connectivity: Standalone console with touch-screen. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.

Indications for Use

Indicated for aesthetic, cosmetic, and surgical soft tissue applications including treatment of benign vascular/pigmented lesions, hair removal, pseudofolliculitis barbae, and topical heating for pain relief/muscle relaxation. Applicable to Fitzpatrick skin types I-VI depending on module.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Alma Harmony XL Platform (K072564)
• The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms (K140009)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three overlapping profiles facing right, resembling a family or group of people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2015

Alma Lasers Incorporated % Ms. Kathy Maynor USA Regulatory 26 Rebecca Court Homosassa, Florida 34446

Re: K141237 Trade/Device Name: Alma Harmony Lite Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONF, ILY Dated: February 4, 2015 Received: February 6, 2015

Dear Ms. Maynor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141237

Device Name Alma Harmony Lite

## Indications for Use (Describe)

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) 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, 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, 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, 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 contactcooling) is indicated for: •The treatment of pseudofolliculitis barbae (PFB).

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•The removal of unwanted hair and to effect stable long-term or permanent hair 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 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 or pigmented lesions).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Section 8 - 510(k) Summary or 510(k) Statement

#### I. General Information

| Submitter: | Alma Lasers Inc.<br>485 Half Day Rd. Suite 100<br>Buffalo Grove, IL 60089 |
|---------------------------|---------------------------------------------------------------------------|
| Contact Person: | Avi Farbstein<br>General Manager, EVP<br>Alma Lasers Inc. |
| | Kathy Maynor<br>USA Regulatory<br>Alma Lasers Inc. |
| Summary Preparation Date: | March 12, 2015 |

#### II. Names

| Device Names: | Harmony Lite Multi-Application Platform |
|-------------------------------|-----------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Surgical Powered Light Instrument, Ultraviolet Dermatological<br>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 Description

The Alma Lasers Harmony Lite Multi-Application Platform is comprised of the following main components:

- . The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer.
- Variety of handpieces, including IPL, LED and NIR modules ●
- Footswitch.

#### V. Indications for Use

The Alma Lasers Harmony Lite Multi-Application Platform is intended for use in dermatologic and general surgical procedures.

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The Indications for Use of the Harmony Lite Multi-Application Platform are provided in the tables below.

| | Dye VL Pro IPL Handpiece – this submission | K072564 - Alma<br>VL515 IPL handpiece |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength<br>(nm) | 500-600nm | VL515 Handpiece<br>(515nm-950nm) |
| Intended Use | Intended for use in aesthetic and cosmetic<br>applications requiring selective photothermolysis<br>(photocoagulation or coagulation) and hemostasis<br>of soft tissue in the medical specialties of general<br>and plastic surgery, and dermatology | Intended for use in aesthetic and cosmetic<br>applications requiring selective photothermolysis<br>(photocoagulation or coagulation) and hemostasis<br>of soft tissue in the medical specialties of general<br>and plastic surgery, and dermatology |
| Indications for<br>Use | Indicated for the treatment of:<br>• Benign cutaneous vascular lesions,<br>including port wine stains, hemangiomas,<br>facial, truncal and leg telangiectasias,<br>rosacea, erythema of rosacea,, angiomas<br>and spider angiomas, poikiloderma of<br>Civatte, leg veins and venous<br>malformations<br>• For Use on skin types (I-V) | Indicated for the treatment of:<br>• Moderate inflammatory acne (acne<br>vulgaris)<br>• Tattoos and benign pigmented epidermal<br>and cutaneous lesions including warts,<br>scars ,striae; dyschromia,<br>hyperpigmentation, melasma, epithelides<br>(freckles), lentigines, nevi, and café-au-lait<br>macules<br>• Benign cutaneous vascular lesions,<br>including port wine stains, hemangiomas,<br>facial, truncal and leg telangiectasias,<br>rosacea, erythema of rosacea, angiomas<br>and spider angiomas, poikiloderma of<br>Civatte, leg veins and venous<br>malformations<br>• For use on skin types (I-V) |
| Pulse Width | 10,12,15 | 10, 12, 15 |
| (msec) | | |
| Pulse<br>Repetition<br>Rate (Hz) | 2/3 | 2/3 |
| Energy<br>Density<br>(Fluence)<br>(J/cm²) | 10-30 | 10-30 |
| Spot Size<br>(mm) | 3 cm² | 3 cm² |
| | VP PRO – this submission | Previously Cleared K072564 – Alma IPL<br>handpiece VL/PL, VP and SSR |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength | 540-950nm | 540-950nm |
| Intended Use | Intended for use in aesthetic and cosmetic<br>applications requiring selective<br>photothermolysis (photocoagulation or<br>coagulation) and hemostasis of soft tissue<br>in the medical specialties of general and<br>plastic surgery, and dermatology | Intended for use in aesthetic and cosmetic<br>applications requiring selective<br>photothermolysis (photocoagulation or<br>coagulation) and hemostasis of soft tissue in<br>the medical specialties of general and plastic<br>surgery, and dermatology |
| Indications for Use | Indicated for the treatment of:<br>The treatment of benign pigmented<br>epidermal lesions including<br>dyschromia, hyperpigmentation,<br>melasma, and ephelides (freckles),<br>lentigines, nevi, melasma, and<br>cafe-au-lait macules. The treatment of benign cutaneous<br>vascular lesions including port<br>wine stains, hemangiomas, facial,<br>truncal and leg telangiectasias,<br>rosacea, erythema of rosacea,<br>angiomas and spider angiomas,<br>poikiloderma of Civatte, leg veins<br>and venous malformations. Use on all skin types (Fitzpatrick I-<br>VI). | The treatment of moderate<br>inflammatory acne vulgaris. The treatment of benign pigmented<br>epidermal lesions including dyschromia<br>hyperpigmentation, melasma, and<br>ephelides (freckles), lentigines, nevi,<br>melasma, and cafe-au-lait macules. The treatment of cutaneous lesions<br>including warts, scars and striae. The treatment of benign cutaneous<br>vascular lesions including port wine<br>stains, hemangiomas, facial, truncal and<br>leg telangiectasias, rosacea, erythema of<br>rosacea, angiomas and spider angiomas,<br>poikiloderma of Civatte, leg veins and<br>venous malformations. The removal of unwanted hair to effect<br>stable long-term or permanent hair<br>reduction. Use on all skin types (Fitzpatrick I-VI). |
| Energy Density<br>(Fluence) (J/cm2) | 10-30 | 10-30 |
| Pulse Repetition<br>Rate (Hz) | 2/3 | 2/3 |
| Pulse Width<br>(msec) | 10, 12, 15 | 10, 12, 15 |
| Spot size | 3 cm2 | 3 cm2 |
| | This submission – SSR IPL handpiece | K072564 - Alma |
| | | SR IPL handpiece |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength<br>(nm) | 570-950 | 570-950 |
| Intended Use | Intended for use in aesthetic and cosmetic<br>applications requiring selective<br>photothermolysis (photocoagulation or<br>coagulation) and hemostasis of soft tissue in<br>the medical specialties of general and<br>plastic surgery, and dermatology | Intended for use in aesthetic and cosmetic<br>applications requiring selective<br>photothermolysis (photocoagulation or<br>coagulation) and hemostasis of soft tissue in<br>the medical specialties of general and plastic<br>surgery, and dermatology |
| Indications for<br>Use | The Advanced Fluorescence<br>Technology (AFT) 570-950 nm SSR<br>Module handpiece (with and without<br>contact-cooling) is indicated for:<br>● The treatment of benign pigmented<br>epidermal lesions, including<br>dyschromia, hyperpigmentation,<br>melasma and ephelides (freckles).<br>● The treatment of face and body<br>vascular and pigmented lesions.<br>● The treatment of cutaneous lesions,<br>including scars and striae.<br>● The treatment of benign cutaneous<br>vascular lesions, including port<br>wine stains, hemangiomas, facial,<br>truncal and leg telangiectasias,<br>rosacea, melasma, angiomas and<br>spider angiomas, poikiloderma of<br>Civatte, leg veins and venous<br>malformations.<br>● Use on all skin types (Fitzpatrick I-<br>VI). | The Advanced Fluorescence Technology<br>(AFT) 570-950 nm SR Module handpiece<br>(with and without contact-cooling) is<br>indicated for:<br>● The treatment of moderate<br>inflammatory acne vulgaris.<br>● The treatment of benign pigmented<br>epidermal lesions, including<br>dyschromia, hyperpigmentation,<br>melasma and ephelides (freckles).<br>● The treatment of face and body<br>vascular and pigmented lesions.<br>● The treatment of cutaneous lesions,<br>including scars and striae.<br>● The treatment of benign cutaneous<br>vascular lesions, including port wine<br>stains, hemangiomas, facial, truncal<br>and leg telangiectasias, rosacea,<br>melasma, angiomas and spider<br>angiomas, poikiloderma of Civatte,<br>leg veins and venous malformations.<br>● The removal of unwanted hair to<br>effect stable long-term or permanent<br>hair reduction.<br>● Use on all skin types (Fitzpatrick I-<br>VI). |
| Energy Density<br>(Fluence)<br>(J/cm²) | 10-25 J/cm² | 10-25 J/cm² |
| Pulse<br>Repetition Rate<br>(Hz) | 2/3 | 2/3 |
| Pulse Width<br>(msec) | 10,12,15 msec | 10, 12, 15 msec |
| Spot size (mm) | 3 cm² | 3, 6 cm² |
| | This submission<br>SHR IPL handpiece | Previously Cleared K072564 - Alma SHR IPL |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength<br>(nm) | 780-950 | 780-950 |
| Intended Use | Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology | Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology |
| Indications for Use | The Advanced Fluorescence Technology (AFT) 780-950 rnm SHR Module handpiece (with and without contact-cooling) is indicated for:<br>• Removal of unwanted hair<br>Effect stable or permanent hair reduction.<br>Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime<br>• The treatment of pseudofolliculitis barbae (PFB).<br>• Use on all skin types (Fitzpatrick I-VI), including tanned skin | The Advanced Fluorescence Technology (AFT) 780-950 rnm SHR handpieces (with and without contact-cooling) is indicated for:<br>• The treatment of pseudofolliculitis barbae (PFB).<br>• The removal of unwanted hair and to effect stable long-term or permanent hair reduction.<br>• Use on all skin types (Fitzpatrick I-VI), including tanned skin. |
| Pulse Width<br>(msec) | 30,40,50 msec…