(40 days)
The SkinClear Q-Switched Nd: YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal, the removal of pigmented lesions. and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV)
The SkinClear Q-Switched Nd: YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV)
The SkinClear Q-Switched Nd: YAG Laser is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD), a handpiece which contains the light source which is connected to the console by a power cord, and an on/off footswitch.
The provided text does not describe acceptance criteria for a study or data proving a device meets such criteria. Instead, it is a 510(k) summary for the SkinClear Q-Switched Nd:YAG Laser, submitted to the FDA. This document states that no nonclinical or clinical performance data was provided to support the submission.
The FDA's determination of substantial equivalence for this device was based on a comparison of its technological characteristics to a legally marketed predicate device (Sandstone Medical Technologies, LLC UltraLight II Nd:YAG Laser System (K041011)). The key aspect of this comparison was that both devices share the same wavelengths, energy output, pulse duration, and pulse repetition rate.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are reported.
- Sample size used for the test set and the data provenance: No test set was used as no clinical or nonclinical studies were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data was provided.
- Adjudication method for the test set: Not applicable, as no test set data was provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study was done, as no clinical data was submitted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
- The type of ground truth used: No ground truth was established, as no performance studies were conducted.
- The sample size for the training set: Not applicable, as no training set was used.
- How the ground truth for the training set was established: Not applicable, as no training set was used.
§ 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.