(29 days)
The Photosilk and Photosilk Plus systems are indicated for permanent hair reduction, and the treatment of benign vascular and pigmented lesions.
The Photosilk and Photosilk Plus pulsed light system is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions and leg veins, indicated for photocoagulation of and the treatment of benign pigmented lesions.
The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal effects and discomfort associated with light applications.
Photosilk and Photosilk Plus are intense pulsed light systems, having a Xenon flashlamp located in the handpieces. It is a light source with a wavelength range of approximately 400 - 1200nm. Light emission activation is by foot switch. Overall weight of the laser is 65 Kg, and the size is 103x50x48 cm (HxWxD). Electrical requirement is 220 VAC, 15A, 50-60 Hz, single phase. Skin cooling is provided by the integrated cooling handpiece that contains cooled water circulated through the handpiece body, the face of which is in contact with the skin.
The provided document is a 510(k) summary for the Photosilk and Photosilk Plus intense pulsed light systems, filed in 2004. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness based on new clinical studies with defined acceptance criteria.
Therefore, the document does not contain the requested information regarding acceptance criteria for device performance, or details of a study designed to prove the device meets such criteria. Specifically, the "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none."
The summary indicates that the device's equivalence is based on having the "same principle of operation, the same wavelength and essentially the same power range as the predicate device for the same indications for uses." This means its acceptance stemmed from a comparison to a previously cleared device, not from an independent study demonstrating specific performance metrics against pre-defined acceptance criteria.
Response to Specific Questions based on the provided document:
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A table of acceptance criteria and the reported device performance:
Not applicable. The document does not define specific performance acceptance criteria for the Photosilk/Photosilk Plus, nor does it report performance data from a study against such criteria. The device's acceptance is based on substantial equivalence to a predicate device. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new clinical or non-clinical performance data (test set) was presented for this 510(k) submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No test set requiring expert ground truth was described. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set requiring adjudication was described. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an intense pulsed light system, not an AI-driven diagnostic or assistive tool. No MRMC study was mentioned. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an intense pulsed light system, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new clinical study was conducted. -
The sample size for the training set:
Not applicable. This device relies on substantial equivalence, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable. This device relies on substantial equivalence, not a machine learning model.
§ 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.