(206 days)
The StarLite-LM is a hand held device intended for Over The Counter patient usage to specifically reduce periorbital wrinkles. The target patient population would be identical to the population of the predicate device. StarLite-LM emits LED light energy in the Red and Infrared region.
StarLite-LM is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade polycarbonate lens from which high spectral purity LED light in 2 (two) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are user selected via a simple pushbutton on alternate treatment days and are in the visible Red and the Infrared spectrum. StarLite-LM is powered by a built in Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for both light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation.
The provided text does not contain any acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a 510(k) summary for the StarLite-LM device. In a 510(k) submission, the manufacturer primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against pre-defined acceptance criteria.
Here's what the document does state regarding performance:
- Performance Data: "Based on analysis of the performance, safety and effectiveness characteristics for StarLite-LM, PS Advanced Engineering believes that no significant differences in those specific characteristics exists between the StarLite-LM and the previously approved Photo Therapeutics Limited New-U (K072459). Therefore StarLite-LM raises no new questions of safety or effectiveness."
This statement indicates that the manufacturer asserts their device is similar in performance to the predicate device, but it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against those criteria.
- Details of a study proving such performance (e.g., sample size, experts, ground truth, MRMC study, standalone performance).
Therefore, I cannot fulfill the request to provide the acceptance criteria and the study details because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device (Omnilux New-U (K072459)) for the indication of reducing periorbital wrinkles, rather than presenting a performance study with acceptance criteria for the StarLite-LM itself.
§ 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.