(265 days)
alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;
in combination with an adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;
dermal pigmented lesions (dermal melanocytosis); and
for tattoo removal (dark and blue inks).
The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF.
The LT-100 will be limited to use by licensed professionals (as provided in 21 CFR 801.109).
The LT-100 Laser Treatment System is a Q-Switched Nd:YAG which emits its energy at 1064 nm.
This document is a 510(k) summary of safety and effectiveness for the LT-100 Laser Treatment System. It states that performance data was not required for this device because its specifications and intended uses are the same as or very similar (substantially equivalent) to those of the claimed predicate devices (ThermoLase SoftLight, Continuum Biomedical, Inc., Medlite™ and Medlite™ IV Q-Switched Nd:YAG Lasers). Therefore, there is no study provided within this document that details acceptance criteria and device performance in the way typically expected for novel devices requiring clinical validation.
As a result, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.
The core of the submission is a claim of substantial equivalence, meaning the FDA did not require new performance data to be submitted for this device.
§ 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.