(26 days)
No
The summary does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development. The device description focuses on the hardware and different light-based technologies.
Yes
The device is explicitly stated to be for "therapeutic" use in several sections of the document, including the description of the device as a "Class II Medical Device" and in the performance studies section (e.g., "surgical, cosmetic, therapeutic and diagnostic laser equipment"). Its indications for use also include treatment of various medical conditions, such as acne vulgaris, vascular lesions, and pain relief.
No
The device description and intended use clearly state that the Alma Harmony is intended for "aesthetic and cosmetic applications," "dermatologic, aesthetic procedures and pain management procedures," and "The treatment of benign pigmented epidermal lesions," "The treatment of benign cutaneous vascular lesions," etc. These are all therapeutic or cosmetic treatments, not diagnostic functions. The performance studies also include "Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment," but this refers to the IEC standard which covers a broad range of devices, not what this specific device does. The device itself is described as a "multi-technology platform" for "treatment."
No
The device description clearly states it is a "micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface" and has "6 applicators that are attached to the console". This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for aesthetic and cosmetic applications, as well as pain management, through the application of light energy (photothermolysis, photocoagulation, coagulation, hemostasis, topical heating). These are all procedures performed directly on the patient's body.
- Device Description: The device is described as a platform with multiple applicators that emit light energy. This aligns with a therapeutic or aesthetic device, not a device that analyzes samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies listed focus on electrical safety, electromagnetic compatibility, and biological evaluation, which are typical for medical devices used on the body, not IVDs. There are no studies related to analytical or clinical performance of analyzing biological samples.
- Predicate Devices: The predicate devices listed are also light-based systems used for similar aesthetic and therapeutic purposes.
In summary, the device's function, intended use, and the nature of the provided information all indicate that it is a therapeutic/aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Iris VL / PL Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery, and dermatology.
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, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, 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, the treatment of cutaneous lesions including warts, scars and striae, the treatments 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 and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin
Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (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 cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Iris NIR Applicator:
Intended to emit energy in the infra-red 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 muscular back pain.
Iris Diode Applicator
The Iris diode is intended for use for vascular lessons, spider naevi, teleangiectasis, red superficial veins o fthe legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
Product codes
GEX, ILY, ONF
Device Description
The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
There are 6 separate applicators. Each handpiece has its own indication for use.
- Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm ●
- Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of ● 500nm-600nm
- Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm
- Iris Acne is an IPL handpiece operating in the wavelength range of 420nm 950nm ●
- Iris NIR is near infrared with a wavelength of 1300nm ●
- Iris Diode is a 520nm diode laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, benign pigmented epidermal lesions, benign cutaneous vascular lesions, tattoos, cutaneous lesions (warts, scars, striae), unwanted hair, muscle, joints, back, vascular lesions, spider naevi, telangiectasia, red superficial veins of the legs and face.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical special and plastic surgery, and dermatology.
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
The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility.
IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60601-2-57 Particular requirements for basic safety and essential performance of nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
In addition, software verification and validation testing was performed.
Key Metrics
Not Found
Predicate Device(s)
K222064, K141237, K181298, K072564, K053604
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2023
Alma Lasers, Inc. Jessica Rivera Montejo Director Regulatory Affairs and Quality 485 Half Day Road #100 Buffalo Grove, Illinois 60089
Re: K230308
Trade/Device Name: Alma Harmony 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: GEX. ILY. ONF Dated: February 2, 2023 Received: February 3, 2023
Dear Jessica Rivera Montejo:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black against a white background. The name appears to be a signature or label.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230308
Device Name Alma Harmony
Indications for Use (Describe)
Iris VL / PL Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery, and dermatology.
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, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, 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, the treatment of cutaneous lesions including warts, scars and striae, the treatments 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 and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin
Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (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 cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine
3
stains hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Iris NIR Applicator:
Intended to emit energy in the infra-red 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 muscular back pain.
Iris Diode Applicator
The Iris diode is intended for use for vascular lessons, spider naevi, teleangiectasis, red superficial veins o fthe legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
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 7 510(k) Summary-K230308
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
I. Submitter Information [21 CFR 807.92(a) (1)]
| Owner Name | Alma Lasers Inc. |
|---|---|
| Address | 485 Half Day Rd. Suite 100 |
| Buffalo Grove, IL 60089 | |
| Contact Person | Jessica Rivera-Montejo |
| 224-377-2000- phone | |
| Jessica.rivera-montejo@almalasers.com | |
| Summary Preparation Date | February 2, 2023 |
II. Name of device [21 CFR 807.92 (a) (2)]
| Trade or Proprietary Name | Alma Harmony | ||
|---|---|---|---|
| Common Device Name(s) and | |||
| Regulatory Class | Product | ||
| Code(s) | Classification Panel | Regulation | |
| Laser Surgical Instrument for | |||
| use in general and plastic | |||
| surgery and in dermatology | |||
| Class II | GEX | General & Plastic | |
| Surgery Panel, 79 (SU) | § 21 CFR 878.4810 | ||
| Lamp, Infrared Therapeutic | |||
| Class II | ILY | General & Plastic | |
| Surgery Panel, 79 (SU) | § 21 CFR 890.5500 | ||
| Powered Light Based Non- | |||
| Laser Surgical Instrument | |||
| with thermal effect | ONF | General & Plastic | |
| Surgery Panel, 79 (SU) | § 21 CFR 878.4810 |
III. Predicate and Reference Devices [21 CFR 807.92(a) (3)]
There are 6 applicators included in this submission. Each applicator has its own indication for use. As a result, there are 5 primary predicate devices. Below is the list predicate devices and which applicator utilizes which predicate device. Predicate Devices
| Subject Applicator | 510(k) # | Trade Name | Product
Code |
|--------------------|----------|-------------------------------------|-----------------|
| Iris NIR | K222064 | Soprano Titanium | GEX, ILY |
| Iris VL / PL | K141237 | Alma Harmony Lite | ONF, ILY |
| Iris SHR Mode | | | |
| Iris Dye VL / SVL | K181298 | Harmony XL Multi-Application System | GEX, ONF |
| Iris Acne | K072564 | Harmony XL Multi-Application System | GEX |
| Iris HR Mode | | | |
| Iris Diode | K053604 | Wavelight IDAS | GEX |
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Reference Devices
| Subject Applicator | 510K # | Trade Name | Product Code |
|---|---|---|---|
| Iris Dye VL / SVL | K033946 | Lovely Family | GEX |
| Iris SHR | K033946 | Lovely Family | GEX |
IV. Device Description [21 CFR 807.92(a) (4)]
The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It has 6 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
There are 6 separate applicators. Each handpiece has its own indication for use.
- Iris VL / PL is an IPL handpiece operating in the wavelength range of 540nm-950nm ●
- Iris Dye VL and Dye SVL is an IPL handpiece operating in the wavelength range of ● 500nm-600nm
- Iris SHR is an IPL handpiece that operates in the wavelength range of 650nm-950nm
- Iris Acne is an IPL handpiece operating in the wavelength range of 420nm 950nm ●
- Iris NIR is near infrared with a wavelength of 1300nm ●
- Iris Diode is a 520nm diode laser.
V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]
Indications for Use
Iris VL / PL Applicator
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
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).
6
Iris Dye VL / Dye SVL Applicator
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • 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 skin types (Fitzpatrick I-V).
Iris SHR Applicator
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: * The treatment of tattoos. * 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. • 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 and to effect stable longterm or permanent hair reduction. • Use on all skin types (Fitzpatrick I-VI), including tanned skin
Iris Acne Applicator
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
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (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 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.
Use on all skin types (Fitzpatrick I-VI).
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Iris NIR Applicator
Intended to emit energy in the infra-red 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 muscular back pain.
Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider naevi, telangiectasia, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-aulait stains, lentigo), hemangiomas, port wine stains, rosacea.
VI. Summary of technological characteristics of the device compared to the predicate(21 CFR 807.92(a)(6)]
The subject Alma Harmony system shares with the predicate devices the same underlying technology and presents nearly identical technological characteristics. Both systems use laser energy delivered to the skin surface via applicators. Both the Alma Harmony and the predicate devices have the same main functional components consisting of a system console with a user interface, laser and NIR modules, internal electronics and IPL, Laser and NIR applicators.
The subject Alma Harmony is substantially equivalent to the previously cleared predicate devices with respect to hardware and software, principle of operation and product design.
There are very minor changes to the applicators that do not affect safety and efficacy.
The Iris VL / PL Applicator has a fluence of 5-30J/cm² while the predicate device has a fluence of 10-30J/cm². This negligible difference does not raise new concerns for safety or efficacy.
The Iris Dye VL / SVL applicator has a repetition rate of 1/2Hz. The predicate has a repetition rate of 2/3Hz. This negligible difference does not raise new concerns for safety or efficacy.
The Iris HR / SHR applicator has a slightly different fluence. The SHR fluence is 3-7J/cm² for the proposed device and the SHR for the predicate is 1-5J/cm². The HR predicate fluence is 5-25J/cm² and the HR proposed device is 5-20J/cm². The negligible difference does not raise new concerns for safety or efficacy.
8
The Iris Acne applicator has a higher repetition rate of 1Hz. The predicate has a repetition rate of 2/3 Hz. This allows for the treat to be performed faster and does not raise new concerns of safety or efficacy. The energy density falls within the predicate range.
The Iris Diode has a pulse width of 1-100ms which is a subset of the pulsewidth in the predicate device. This does not raise new concerns of safety or efficacy.
VII. Performance Testing [21 CFR 807.92(b)(1)]
The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility.
IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60601-2-57 Particular requirements for basic safety and essential performance of nonlaser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
In addition, software verification and validation testing was performed.
VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission.
IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]
The Alma Harmony is as safe and effective as the predicate devices. The proposed Alma Harmony has the same intended use and indications, similar technological characteristics, and same principle of operation as its predicate devices. Thus, the Alma Harmony is substantially equivalent to its predicate.