(135 days)
The PhotoLight System is indicated for the treatment of benign cutaneous vascular lesions.
The PhotoLight pulsed light system is a medical device utilizing optical energy for photocoagulation of vascular lesions
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary and FDA clearance letter for the Cynosure PhotoLight System. It states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Therefore, I cannot populate the table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The FDA found the device "substantially equivalent" to a predicate device (PhotoDerm VL by ESC Medical Systems) based on its intended use and treatment parameters, not on new clinical performance data from the submitter.
§ 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.