(298 days)
755mm: The CLARITY LPC Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. 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. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm: The CLARITY LPC Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
The CLARITY LPC Laser System contains two separate laser resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device. The CLARITY LPC laser system is configured with an ICD (Intelligent Cooling Device) skin cooling device. The CLARITY LPC Laser System delivers laser energy with various pulse durations from 0.35 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch (finger switch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration). The laser output energy is delivered via an optical fiber to a handpiece which produces circular beams with diameters from 2 to 20 millimeters on the skin. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system.
The provided document is a 510(k) summary for the Lutronic Corporation CLARITY LPC Laser System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving clinical efficacy through extensive studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial would.
Therefore, the document explicitly states: "7. Performance Data None presented."
This clearly indicates that the submission does not contain a detailed study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared device (Candela Corporation GentleMAX Family of Laser Systems, K112715) by comparing technological characteristics (wavelengths, laser source, indications for use, treatment parameters, etc.).
Given this explicit statement, I cannot provide the requested information about acceptance criteria, a study proving it, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.
The document's purpose is to show that the new device is as safe and effective as the predicate device without needing new clinical performance data, as the technological characteristics and intended uses are highly similar.
§ 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.