(14 days)
The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles) * Benign cutaneous lesions including warts, scars, and striae
560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae
585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae
640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.
The NannoLight Intense Pulsed Light System (K082033) 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Instead of presenting performance data, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices (Sciton Profile BBL System (K032460) and Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems (K020839)) for its clearance. This means that the device's safety and effectiveness are supported by its similarity in design, intended use, and operational principles to already approved devices, rather than a novel study demonstrating its specific performance against defined metrics.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided text.
§ 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.