(147 days)
The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins.
The ADVANTAGE Laser System with the D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9. and 12 months.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (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 ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, caféau-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The ADVANTAGE Laser System with D1-1064 Handpiece is a treatment handpiece, intended to be used with ADVANTAGE Laser System 510(k) cleared in K113502 on April 5, 2012. The ADVANTAGE Laser System with D1-1064 Handpiece delivers laser energy through a 10 x 10 mm tip with a fluence of up to 100 J/cm2. The settings for this handpiece are pulse duration from 5-400 msec, and a pulse repetition rate up to 3 Hz maximum. The ADVANTAGE Laser System with D1-1064 Handpiece is water-cooled to provide active skin cooling.
This document is a 510(k) premarket notification for the Lutronic Corporation ADVANTAGE Laser System. It discusses the device's indications for use and states that it is substantially equivalent to previously cleared predicate devices.
However, the document explicitly states: "7. Performance Data: None presented."
Therefore, based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets such criteria. The document relies on substantial equivalence to predicate devices rather than new performance data.
As a result, I cannot provide the requested information in the table or answer the specific questions about sample sizes, ground truth, experts, adjudication, or MRMC studies, as this data 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.