(119 days)
The StarLux™ Pulsed Light system is indicated for:
- The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.
- The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and café-au-lait.
- The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The StarLux™ is a versatile, light-based medical device consisting of a base unit and handpiece attachments.
The provided text describes a 510(k) submission for the Palomar StarLux™ Pulsed Light System. In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, stating, "The differences in the specifications of the StarLux™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This means no new performance data or acceptance criteria were reported in this summary.
- Sample sized used for the test set and the data provenance: Not applicable, as a new study proving performance against acceptance criteria was not conducted for this 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 document is for a pulsed light system, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary concludes that the StarLux™ System is "substantially equivalent" to the EsteLux™ Pulsed Light System and Lumenis VascuLight based on the fact that "differences in the specifications... do not result in different performance or raise new questions of safety or efficacy." This type of submission relies on the established safety and efficacy of the predicate devices.
§ 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.