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MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200mm (including 8 filters) Light:

1. Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).

2. Cutaneous lesions, including warts, scars and striae.

3. Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations.

4. Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles.

5. Mild to moderate inflammatory Acne (Acne vulgaris)

Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The MULA is a multi-application, multi-technology system, with an IPL&DPL handpiece and 8 different filters: 515nm/ 560mm/ 615nm/ 640mm/ 695nm/ Acne Filter (Notch filter 400-600 and 800-1200) and Vascular Filter (Notch filter 530-650 & 900-1200), and it also equips two precision treatment heads (38x10mm and 8mm diameter).

This document is a 510(k) summary for the MULA (K2-A1) device, a multi-filtered Intense Pulsed Light/Dye Pulsed Light (IPL/DPL) system. The document states that clinical testing was "Not applicable," meaning a study demonstrating the device meets specific acceptance criteria was not included in this submission.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

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