(114 days)
The Magma System is indicated for use in aesthetic applications in dermatology.
The Magma System has connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
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The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of Pseudofolliculitis Barbae (PFB).
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The Magma System with Nd: Y AG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) is indicated for:
· The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
· The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction® in skin types I-V through selective targeting of melanin in hair follicles.
• The non-ablative treatment of facial wrinkles
- The Magma System with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm is indicated for:
HR*, F-HR*, B-HR* Applicators (650-1100nm):
· Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles.
HR, F-HR, B-HR Applicators (590-1100nm):
• Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles.
SR, F-SR, B-SR Applicators (530-1100nm):
· Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles)
· Cutaneous lesions, including striae
· 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. F-AC Applicator (430-1100nm):
T-AC Applicator (+50-1100mm).
· Mild to moderate inflammatory Acne (Acne vulgaris) *Note
Permanent hair reduction 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 Magma System is a computerized multi-application, multi-technology platform, intended for non-invasive aesthetic applications utilizing laser and Intense Pulsed Light (IPL) optical power.
The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including a LCD display and touch screen module. Apart from the system platform the Magma System is provided with 13 applicators divided into three technology related sub-categories:
- ALD & LLD Diode laser (808nm) Applicators for hair removal treatments.
- Multi-spot Nd:YAG laser (1064nm) Applicator for coagulation and hemostasis of vascular lesions and soft tissue, hair removal treatments and non-ablative treatment of facial wrinkles.
- Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories:
- o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V).
- o HR, F-HR & B-HR (590-1100nm) Applicators for hair removal treatments (skin types I-IV).
- o SR. F-SR & B-SR (530-1100mm) Applicators for the treatment of pigmented and vascular lesions.
- o F-AC (430-1100nm) Applicator for acne treatments.
The operator chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the Magma System. The Magma System has two applicator ports; one for IPL based applicators and one for Laser applicators. The ports must be simultaneously connected with both laser and IPL applicators for the system to operate.
The provided text is a 510(k) summary for the Magma System, a multi-application aesthetic device utilizing laser and Intense Pulsed Light (IPL) technology. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report for novel performance claims.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific percentages for hair reduction, lesion clearance). Instead, it relies on demonstrating that its design and components are similar to already cleared predicate devices and that its functionality and mechanism of operation are similar.
Reported Device Performance (based on similarity to predicate devices and general claims):
- Hair Removal/Permanent Hair Reduction:
- ALD/LLD Laser Handpiece: Skin types I-VI.
- Nd:YAG Laser Handpiece: Skin types I-V.
- IPL HR*, F-HR*, B-HR* (650-1100nm) Applicators: Skin types I-V.
- IPL HR, F-HR, B-HR (590-1100nm) Applicators: Skin types I-IV.
- Note: Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment.
- Vascular Lesions/Soft Tissue Coagulation and Hemostasis:
- Nd:YAG Laser Handpiece: Superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
- Non-ablative treatment of facial wrinkles:
- Nd:YAG Laser Handpiece.
- Benign Epidermal Lesions:
- IPL SR, F-SR, B-SR (530-1100nm) Applicators: Dyschromia, hyperpigmentation, ephelides (freckles).
- Cutaneous Lesions:
- IPL SR, F-SR, B-SR (530-1100nm) Applicators: Striae.
- Benign Cutaneous Vascular Lesions:
- IPL SR, F-SR, B-SR (530-1100nm) Applicators: Port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Mild to moderate inflammatory Acne (Acne vulgaris):
- IPL F-AC Applicator (430-1100nm).
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Clinical Performance Data: Not Applicable". This indicates that a separate clinical study with a test set was not conducted or presented for this 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices which have already demonstrated clinical effectiveness.
Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no clinical test set with human-established ground truth was presented.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The Magma System is an aesthetic laser/IPL device for direct treatment, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The Magma System is a physical medical device (laser/IPL system) operated by a human, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for a clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior clearances and the scientific literature supporting the principles of laser and IPL technology for the stated indications.
8. The sample size for the training set:
Not applicable. The document describes a medical device, not an AI algorithm requiring a training set in the conventional sense. The "training" for such a device would be the extensive research and development in laser and IPL technology, manufacturing, and engineering specific to the device's design, which is validated through non-clinical performance tests.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI algorithm submission with a distinct training set and ground truth establishment methodology. The "ground truth" for the device's functionality is demonstrated through compliance with recognized consensus standards (e.g., AAMI/ANSI 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-2-57) and non-clinical performance tests verifying hardware and software functionality and safety. The clinical efficacy is substantially equivalent to predicate devices.
§ 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.