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The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:

• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of tattoos;
• 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 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.

Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:

• The coagulation and hemostasis of vascular lesions and soft tissue, including:
• 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 follicies;
• The non-ablative treatment of facial wrinkles.

LightSheer Diode Laser Wavelength (800 mm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:

• The removal of unwanted hair, and to effect stable long-term, or permanent', hair reduction through selective targeting of melani, in hair follicles;
• The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions;
• The treatment of leg veins;
• The treatment of benign pigmented lesion;
• The treatment of pseudofolliculitis barbae;

The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.

Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:

• The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and thytids.

Lumenis One systems are comprised of the following main components:

• System console;
• Control and Display;
• One or more delivery handpieces, the Treatment Heads (up to three attached out of four handpieces available for each system);
• Skin cooling technology integrated into the handpiece (as applicable);
• Trigger button integrated into the handpiece; an additional safety button integrated into the laser handpieces;
• Remote interlock connector (disables pulse emission when treatment room door is opened).

This 510(k) summary explicitly states that no clinical data was provided for the Lumenis One Family of Systems. The device's substantial equivalence to predicate devices was based on shared indications for use and similar or identical technical specifications, not on new performance studies.

Therefore, the following information cannot be found or accurately described from the provided text:

• A table of acceptance criteria and reported device performance
• Sample sizes used for test sets
• Data provenance for test sets
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance results
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document makes a direct statement that is crucial for understanding why these details are absent:

"Clinical data therefore was not provided." (Section VII, page 2)

The rationale for not providing clinical data is that:
"The Lumenis One Family of Systems share the same indications for use and the same or similar technical specifications as the currently marketed predicate Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain technical specifications are not significant and they do not alter the safety or effectiveness of the Lumenis One Family of Systems." (Section VII, page 2)

In summary, the device's acceptance criteria were implicitly met by demonstrating substantial equivalence to already cleared predicate devices, without the need for new clinical performance studies or establishing new acceptance criteria and demonstrating compliance.

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