(356 days)
The PhotoSilk Plus Pulsed Light System is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
The PhotoSilk Plus Pulsed Light System Laser Attachment is intended for: Er: Y AG 2,940 mm - for skin resurfacing and for the incision, ablation or vaporization of soft bodily tissues.
Long Pulse Nd: Y AG 1,064 nm - for the treatment of vascular lesions, pigmented lesions, wrinkles and for permanent hair reduction ..
Q-Switched Nd: Y AG 1,064 nm - for dark tattoo removal, and the treatment of pigmented lesions.
The PhotoSilk Plus Pulsed Light System and Laser Attachment provides 400-1200nm pulsed light, 2,940nm Er:YAG, 1064nm Nd:YAG and 1064nm Q-Switched Nd:YAG wavelengths. Laser emission activation is by foot switch. Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Cynosure PhotoSilk Plus Pulsed Light System and Laser Attachment. It explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
Therefore, based on the provided document:
- A table of acceptance criteria and the reported device performance: Not applicable. No performance data or acceptance criteria are provided.
- 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 test set data is provided.
- 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 ground truth establishment for a test set is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is mentioned.
- 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. No MRMC study or AI assistance is mentioned as this device is a medical laser system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system and does not involve algorithms or standalone performance testing in this context.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is mentioned.
- The sample size for the training set: Not applicable. No training set is mentioned.
- How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.
Conclusion: The 510(k) submission for the Cynosure PhotoSilk Plus Pulsed Light System and Laser Attachment did not include any nonclinical or clinical performance data. The device's substantial equivalence was based on its similarity to predicate devices in terms of indications for use, principle of operation, and similar performance specifications, rather than new performance data with acceptance criteria.
§ 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.