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1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.

The 1064nm fractional mode is indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.

532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Cafe-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology.

The Iris Diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

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I am sorry, but the provided FDA 510(k) clearance letter for the Alma Harmony Laser Device (K243044) does not contain the detailed information required to answer your request regarding acceptance criteria and the study that proves the device meets those criteria.

The letter primarily focuses on:

• Confirming the substantial equivalence determination for the device based on its indications for use.
• Listing relevant regulations and requirements for medical device manufacturers.
• Providing contact information for regulatory inquiries.
• Stating that the submitter will make information on safety and effectiveness available upon request.

Here's what is missing from the provided text that would be necessary to answer your specific questions:

• Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, power output tolerances, treatment efficacy rates) that the device must meet, nor does it list numerical targets for these metrics. Laser devices typically have performance specifications related to wavelength, energy, pulse duration, spot size, etc., but these are not present as acceptance criteria in this document.
• Study Design and Results: There is no mention of a clinical or technical study conducted to prove the device meets performance criteria. The letter doesn't include:
  • Performance data: No tables of reported device performance.
  • Sample size and data provenance: No details on test sets, training sets, or where data came from.
  • Ground truth establishment: No information on how ground truth was determined (e.g., expert consensus, pathology, outcomes).
  • Expert qualifications or adjudication: No details on experts, their number, or adjudication methods.
  • MRMC or standalone studies: No mention of these types of studies or their outcomes.
  • Effect size of AI assistance: Not applicable as this is a laser device, not an AI diagnostic tool.

In summary, to answer your questions, I would need a different type of document, such as:

• The 510(k) summary document itself: Submissions typically include a summary of the data and methods used to demonstrate substantial equivalence, which might contain some of this information.
• Clinical study reports: Detailed reports of any studies conducted.
• Performance testing protocols and results.

Without this information, I cannot fulfill your request.

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The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Clear Skin Pro 1540nm Applicator:
The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

SupErb 2940nm Applicator:
The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.
Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.

Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology.

ClearVas Nd:YAG 1064nm
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

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, 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 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 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, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, 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 lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.

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 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).

This document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the Alma Harmony device to previously cleared predicate devices. It describes the device, its intended use, and a comparison of its technological characteristics with the predicate devices. The document references performance testing and animal studies. However, it does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving such a device meets those criteria.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on demonstrating the substantial equivalence of the Alma Harmony, which is a laser and light-based medical device, to existing laser and light-based devices. There is no mention of AI or machine learning components with specific performance criteria or studies in the context of diagnostic accuracy, human-in-the-loop performance, or standalone algorithm performance.

The section titled "Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's 'Guidance for the Content of Premarket Submissions Contained in Medical Devices." is the only mention of software, and it's a general statement about V&V testing, not specific to AI/ML or its performance metrics. The statement "this submission will add the Smart Clinic Software. This software was previously cleared in the Alma Titanium K230371" confirms that any software component is previously cleared, implying it's not a novel AI/ML component being tested for new performance criteria.

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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).
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).
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
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).
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.
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.

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.

The provided text is a 510(k) Premarket Notification from the FDA regarding Alma Lasers, Inc.'s Alma Harmony device. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving that the device meets specific performance-based acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets them, particularly regarding AI-assisted performance, reader studies, or detailed performance metrics. The crucial sentence in Section VIII states: "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."

This means the submission relies on bench testing, software verification/validation, and comparison to predicate devices to demonstrate safety and effectiveness, rather than a clinical trial with acceptance criteria for performance.

Therefore, I cannot populate the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/performance study, as this information is not present in the provided document.

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