(78 days)
The Photolight Pulsed Light device is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
The CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.
Photolight PL is a intense pulsed light system, having a Xenon flashlamp located in the handpieces. It is a light source with a range approximately 400 - 1400 nm wavelength. Emission activation is by footswitch. Overall weight of the laser is 18 Kg, and the size is 20x48x54 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure Photolight PL does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.
Here's a breakdown of why this information is missing and what the 510(k) summary does indicate:
Analysis of the Provided Text:
The "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none." This means no performance data was submitted with this 510(k) application to demonstrate the device's efficacy or safety through specific tests or studies.
The basis for clearance is substantial equivalence to a predicate device (EsteLux pulsed light system). The summary states: "The Photolight PL system has an equivalent indication for uses, the same principle of operation, and essentially the same wavelength range and pulse energy range as the predicate device."
Therefore, it's impossible to create the table and answer the questions requested based on the given input, as no such performance data, acceptance criteria, or study details are present.
What the absence of this information implies in the context of a 510(k):
- Reliance on Predicate Device: For 510(k) clearances, devices often demonstrate safety and effectiveness by showing substantial equivalence to a legally marketed predicate device. This means the FDA determined that the new device is as safe and effective as a previously cleared device, often without requiring new clinical trials if the technological characteristics and intended use are sufficiently similar.
- No Specific Performance Metrics Established for This Device's Clearance: While the device would likely have internal design specifications and quality control checks, these are not typically acceptance criteria used for regulatory clearance in the same way clinical or bench test performance metrics would be. The clearance was not based on the device achieving specific performance targets in a study, but rather on its similarity to an already cleared device.
Conclusion:
Since the 510(k) summary explicitly states "none" for both nonclinical and clinical performance data, it is not possible to describe acceptance criteria or a study proving the device meets them from the provided text. The device received clearance based on substantial equivalence to a predicate device, which did not necessitate new performance studies for this particular submission.
§ 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.