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The subject Lumenis M22 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:

1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 different filters) is indicated for:

· Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos

· Cutaneous lesions, including warts, scars and 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

• 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

· Mild to moderate inflammatory Acne (Acne vulgaris)

2. The Nd: Y AG Laser handpiece 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 and clearance 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

3. ResurFX module and handpiece, with wavelength of 1565 pm, is indicated for:

· Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

4. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:

• Removal of dark tattoos .
• · Treatment of pigmented lesions

*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 subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:

• Universal Intense Pulsed Light (IPL) handpiece (K083733) .
• Multi-Spot Nd:YAG laser handpiece (K083733)
• ResurFX non-ablative laser handpiece (K130028) .
• Q-Switched Nd: Y AG laser handpiece (K043173) ●

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lumenis M22 System:

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices, rather than providing detailed acceptance criteria and standalone study reports for the new device itself. Therefore, much of the requested information (e.g., specific acceptance criteria values, performance metrics against those criteria, detailed study design for a new device, number of experts for ground truth, adjudication methods, MRMC study results, training set details) is not present in this document.

The document primarily relies on the established safety and efficacy of its predicate devices and the fact that its components are either identical or very similar to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, this document does not present specific quantitative acceptance criteria or a table of performance metrics for the Lumenis M22 against such criteria. The "Performance Bench Tests" section generally states: "Bench testing demonstrated that the subject Lumenis M22 System is as safe and effective as the cleared predicate devices," but no specific numerical results or targets are provided.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not specified. The document states that the safety and efficacy are "well established in scientific research and clinical studies" using "these and similar systems," implying reliance on existing literature and prior clearances rather than a new standalone test set for the M22 system itself.
• Data provenance: Not specified. Given the reliance on existing literature and predicate devices, the provenance would be diverse from those prior studies. The document does not indicate new prospective or retrospective data for the M22 system's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not specified. Due to the nature of the 510(k) submission, which relies on equivalence and existing data, there's no mention of a new panel of experts establishing ground truth specifically for the M22 system's performance.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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

• MRMC study: No. This device is a laser/light system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. Therefore, an MRMC study and AI-related effect size are not applicable or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone performance study: The document refers to "Bench testing" and "Summary of Pre-Clinical and Clinical Study" indicating that "The safety and efficacy of all the identified handpieces applied within the subject Lumenis M22 System are well established in scientific research and clinical studies." This suggests reliance on existing data and prior clearances. It does not describe a new, standalone performance study specifically for the M22 system itself as part of this submission, beyond demonstrating that its components function similarly to predicates.

7. The type of ground truth used

• Type of ground truth: Not explicitly stated for a new study. For the predicate devices and existing scientific literature, ground truth would typically be based on:
  • Clinical outcomes: observable reduction in lesions, hair, or wrinkles.
  • Expert assessment: dermatologists or other aesthetic practitioners assessing treatment success.
  • Histopathology: in some cases, for confirmation of lesion types (though less common for aesthetic treatments).

8. The sample size for the training set

• Training set sample size: Not applicable. This is a physical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

• Ground truth for training set: Not applicable (see point 8).

Summary of what is available in the document regarding "proof":

The "proof" for the Lumenis M22 System primarily relies on substantial equivalence to predicate devices.

• Device Components: The M22 System integrates multiple handpieces, each of which is described as being identical or very similar to components of previously FDA-cleared devices (Lumenis Lum One, Lumenis LUME 2, Lumenis ResurFX, Lumenis Quantum, Palomar Lux V, Candela Nd:YAG laser system).
• Minor Differences: Any minor technical differences (e.g., slight fluence increase, additional tip size, minor wavelength differences in filters) are explicitly stated "do not raise any new questions of safety and efficacy."
• Performance Bench Tests: It states that "Bench testing demonstrated that the subject Lumenis M22 System is as safe and effective as the cleared predicate devices," but no details of these tests or specific results are provided.
• Clinical Efficacy and Safety: The document claims, "The safety and efficacy of all the identified handpieces applied within the subject Lumenis M22 System are well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in aesthetic and dermatological procedures, in addition to the devices cleared for marketing by the FDA." This relies on the existing body of evidence supporting the predicate devices and their technologies.
• Compliance with Standards: The device complies with relevant IEC standards (60601-1, 60601-1-2, 60601-2-22, 60825-1, 60601-2-57) pertaining to medical electrical equipment safety, electromagnetic compatibility, and laser/light source equipment. This demonstrates engineering and electrical safety.

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