(304 days)
Not Found
No
The document describes a multi-application laser/light platform with various handpieces for aesthetic and surgical applications. There is no mention of AI, ML, or any image processing or data analysis that would suggest the use of such technologies. The performance studies described are based on animal data and simulations, not on training or testing AI/ML models.
Yes
The device is intended for therapeutic uses, including the treatment of benign cutaneous vascular/pigmented lesions, temporary relief of muscle/joint pain and stiffness, and temporary increase in local circulation.
No
The device is intended for therapeutic and aesthetic applications like ablation, vaporization, excision, incision, photothermolysis of soft tissue, treatment of lesions, hair removal, and pain relief. It does not perform any diagnostic functions.
No
The device description explicitly lists hardware components such as a main console unit, handpieces (IPL, LED, NIR modules), and a footswitch. The intended use also describes physical interactions with tissue (ablation, vaporization, etc.), which are performed by hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The Harmony Lite is a multi-application platform that uses light and laser energy to directly treat soft tissue, skin lesions, hair, muscle pain, and joint pain. It operates externally on the patient's body.
- Intended Use: The intended use clearly describes procedures performed on the patient (ablation, vaporization, excision, etc.) and treatments for various conditions affecting the skin, muscles, and joints.
- Device Description: The components listed (console, handpieces, footswitch) are consistent with a device used for external treatments, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activity typically associated with in vitro diagnostics.
The Harmony Lite is a therapeutic device used for various medical and aesthetic procedures performed directly on the patient.
N/A
Intended Use / 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
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).
Product codes (comma separated list FDA assigned to the subject device)
ONF, ILY
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, cutaneous (skin), facial, truncal, leg, body, muscles, joints, back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties of dermatology, general and plastic surgery, and aesthetic applications.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Alma Harmony Lite was tested by a certified laboratory in accordance with:
IEC 60601-1:2005 + Corr.1 (2006) + Corr. 2 (2007) Medical Electrical Equipment: Part 1 General Requirements for Basic Safety and Essential Performance
IEC60601-1-2: 2007 Medical electrical equipment: Part 1-2; Collateral Standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-57: 2011 1st edition" Medical electrical equipment: Part 2: Particular requirements for the basis safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
The software was documented, verified and validated (test reports in submission) in accordance with IEC 62304:2006 - Medical Device Software: Software Life Cycle Processes and ISO 14971:2012 - Medical Devices: Application of Risk Management to Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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).
3
•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.
485 Half Day Rd. Suite 100
Buffalo Grove, IL 60089 |
|---------------------------|---------------------------------------------------------------------------|
| Contact Person: | Avi Farbstein
General Manager, EVP
Alma Lasers Inc. |
| | Kathy Maynor
USA Regulatory
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 |
| 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.
5
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
VL515 IPL handpiece |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength
(nm) | 500-600nm | VL515 Handpiece
(515nm-950nm) |
| 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 | Indicated for the treatment of:
• Benign cutaneous vascular lesions,
including port wine stains, hemangiomas,
facial, truncal and leg telangiectasias,
rosacea, erythema of rosacea,, angiomas
and spider angiomas, poikiloderma of
Civatte, leg veins and venous
malformations
• For Use on skin types (I-V) | Indicated for the treatment of:
• Moderate inflammatory acne (acne
vulgaris)
• Tattoos and benign pigmented epidermal
and cutaneous lesions including warts,
scars ,striae; dyschromia,
hyperpigmentation, melasma, epithelides
(freckles), lentigines, nevi, and café-au-lait
macules
• Benign cutaneous vascular lesions,
including port wine stains, hemangiomas,
facial, truncal and leg telangiectasias,
rosacea, erythema of rosacea, angiomas
and spider angiomas, poikiloderma of
Civatte, leg veins and venous
malformations
• For use on skin types (I-V) |
| Pulse Width | 10,12,15 | 10, 12, 15 |
| (msec) | | |
| Pulse
Repetition
Rate (Hz) | 2/3 | 2/3 |
| Energy
Density
(Fluence)
(J/cm²) | 10-30 | 10-30 |
| Spot Size
(mm) | 3 cm² | 3 cm² |
| | VP PRO – this submission | Previously Cleared K072564 – Alma IPL
handpiece VL/PL, VP and SSR |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength | 540-950nm | 540-950nm |
| 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 | Indicated for the treatment of:
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 benign cutaneous
vascular lesions including port
wine stains, hemangiomas, facial,
truncal and leg telangiectasias,
rosacea, erythema of rosacea,
angiomas and spider angiomas,
poikiloderma of Civatte, leg veins
and venous malformations. Use on all skin types (Fitzpatrick I-
VI). | The treatment of moderate
inflammatory acne vulgaris. 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
leg telangiectasias, rosacea, erythema of
rosacea, angiomas and spider angiomas,
poikiloderma of Civatte, leg veins and
venous malformations. The removal of unwanted hair to effect
stable long-term or permanent hair
reduction. Use on all skin types (Fitzpatrick I-VI). |
| Energy Density
(Fluence) (J/cm2) | 10-30 | 10-30 |
| Pulse Repetition
Rate (Hz) | 2/3 | 2/3 |
| Pulse Width
(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
(nm) | 570-950 | 570-950 |
| 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) 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). | The Advanced Fluorescence Technology
(AFT) 570-950 nm SR Module handpiece
(with and without contact-cooling) is
indicated for:
● The treatment of moderate
inflammatory acne vulgaris.
● 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.
● The removal of unwanted hair to
effect stable long-term or permanent
hair reduction.
● Use on all skin types (Fitzpatrick I-
VI). |
| Energy Density
(Fluence)
(J/cm²) | 10-25 J/cm² | 10-25 J/cm² |
| Pulse
Repetition Rate
(Hz) | 2/3 | 2/3 |
| Pulse Width
(msec) | 10,12,15 msec | 10, 12, 15 msec |
| Spot size (mm) | 3 cm² | 3, 6 cm² |
| | This submission
SHR IPL handpiece | Previously Cleared K072564 - Alma SHR IPL |
| | | Primary Predicate |
| Characteristic | | |
| Wavelength
(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:
• Removal of unwanted hair
Effect stable or permanent hair reduction.
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
• The treatment of pseudofolliculitis barbae (PFB).
• 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:
• The treatment of pseudofolliculitis barbae (PFB).
• The removal of unwanted hair and to effect stable long-term or permanent hair reduction.
• Use on all skin types (Fitzpatrick I-VI), including tanned skin. |
| Pulse Width
(msec) | 30,40,50 msec | 30,40,50 msec |
| Pulse Repetition
Rate (Hz) | 4 | 4 |
| Energy Density
(Fluence) | 1-5 J/cm2 for SHR
5-25J/cm2 for HR | 1-5 J/cm2 for SHR
5-25J/cm2 for HR |
| Spot Size (mm) | 3 cm2 | 3 cm2 |
VI. Summary of Technical Characteristics
6
7
8
9
| | LED Handpiece - No
modifications - this | Previously Cleared K072564
Alma Lasers LED Handpiece |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | submission | Primary Predicate |
| Characteristic | | |
| Intended Use | Intended for use in dermatologic
procedures | Intended for use in dermatologic
procedures |
| Indications for Use | The 590 nm LED module
handpiece is indicated to: · | 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 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. | Provide topical heating for
●
the purpose of elevating
and/or maintaining tissue
temperature. |
| Wavelength (nm) | 590 (amber) | 590 (amber) |
| Output power
(mW) | 1.800 | 1,800 |
| Treatment Area | 0.9 cm2 (0.14 sq.in.) | 0.9 cm2 (0.14 sq.in.) |
| Mode | Pulsed/Continuous Wave
(CW) | Pulsed/Continuous Wave
(CW) |
10
| | This submission
Alma Lasers NIR Large Module | K140009
Alma Lasers NIR Module |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Primary Predicate |
| Parameter | | |
| Product Code &
Regulation No. | ILY
21CFR 890.5500 | ILY
21 CFR 890.5500 |
| Wavelength [nm] | 1300 | 1300 |
| Lamp Type | Quartz Tube | Quartz tube |
| Intended Use | Intended to emit energy in the infrared
spectrum to provide topical heating for the
purpose of elevating the tissue
temperature | Intended to emit energy in the infrared
spectrum to provide topical heating for
the purpose of elevating the tissue
temperature |
| Indications for Use | 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 muscular
back pain. | 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 muscular
back pain. |
| Power Control | Time control | Time control |
| Mode | Pulsed | Pulsed |
| Fluence [J/cm2] | 0.55-5.5 | 0.55-5.5 |
| Pulse Width [sec] | 1-5 | 1 - 5 |
| Spot Size [mmmm] or cm2] | 18 | 18 |
| Cooling | Contact cooling
Thermo-electric (TEC) | Contact cooling
Thermo-electric (TEC) |
| Treatment Mode | In-motion | In-motion |
| Exposure
Indicator | Audible & visual indicator | Audible & visual indicator |
| How Supplied | Non-sterile, cleanable | Non-sterile, cleanable |
| Module
Dimensions | 1908056mm (LWH) | 1908056mm (LW*H) |
11
| This submission | K140009 | |
|---|---|---|
| Alma Lasers NIR Small Module | Alma Lasers NIR Module | |
| Primary Predicate | ||
| Parameter | ||
| Product Code & | ILY | ILY |
| Regulation No. | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Wavelength [nm] | 1300 | 1300 |
| Lamp Type | Quartz tube | Quartz tube |
| Intended Use | Intended to emit energy in the infrared | |
| spectrum to provide topical heating for | ||
| the purpose of elevating the tissue | ||
| temperature | Intended to emit energy in the infrared | |
| spectrum to provide topical heating for | ||
| the purpose of elevating the tissue | ||
| temperature | ||
| Indications for | ||
| Use | 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 muscular | ||
| back pain. | 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 muscular back pain. | ||
| Power Control | Time control | Time control |
| Mode | Pulsed | Pulsed |
| Fluence [J/cm²] | .55-5.5 | 5.5 |
| Pulse Width [sec] | 1-5 | 1 - 5 |
| Spot Size | ||
| [mm*mm] or | ||
| [cm²] | 6.4 | 6.4 |
| Cooling | Contact cooling | |
| Thermo-electric (TEC) | Contact cooling | |
| Thermo-electric (TEC) | ||
| Treatment Mode | In-motion | In-motion |
| Exposure | ||
| Indicator | Audible & visual indicator | Audible & visual indicator |
| How Supplied | Non-sterile, cleanable | Non-sterile, cleanable |
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Harmony Lite Multi-Application Platform is substantially equivalent to the predicate devices. Additional safety testing was performed as discussed in section 18 of the submission.
The Alma Harmony Lite was tested by a certified laboratory in accordance with:
IEC 60601-1:2005 + Corr.1 (2006) + Corr. 2 (2007) Medical Electrical Equipment: Part 1 General Requirements for Basic Safety and Essential Performance
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IEC60601-1-2: 2007 Medical electrical equipment: Part 1-2; Collateral Standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-57: 2011 1st edition" Medical electrical equipment: Part 2: Particular requirements for the basis safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
The software was documented, verified and validated (test reports in submission) in accordance with IEC 62304:2006 - Medical Device Software: Software Life Cycle Processes and ISO 14971:2012 - Medical Devices: Application of Risk Management to Medical Devices.
VIII. Animal Data
Collateral animal data was presented on a pig study performed at the University of California for the Dye VL Pro handpiece. We compared the results from our IPL experiments to acquired pulsed dye laser (PDL) data from a previous study and determined that IPL treatments can also produce persistent vascular shutdown. We ran Monte Carlo simulations to investigate the relationship between absorbed energy, wavelength, and penetration depth. The data collectively demonstrate the potential to achieve removal of vascular lesions using the IPL.
IX. Conclusion
The Alma Lasers Harmony Lite Multi-Application Platform was found to be substantially equivalent to the predicate devices.
The Alma Lasers Harmony Lite Multi-Application Platform shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.