(201 days)
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:
-
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
-
Cutaneous lesions, including warts, scars and striae.
-
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.
-
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.
-
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.
§ 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.