(27 days)
The ProLite Pulsed Light System is intended to be used in the treatment of vascular lesions.
The Prolite / Plasmalite MPX Pulsed Light System delivers pulsed light at a wavelength of 550 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
The provided document (K022569/A) states under "Performance Data:" that there is "None". Therefore, the remaining requested information regarding acceptance criteria and study details cannot be extracted from this submission.
Here is the table that can be created based on the available information:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Further information regarding the study:
- Sample size used for the test set and the data provenance: Not applicable, as no performance data or study details are provided.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pulsed light system, not an AI algorithm.
- The type of ground truth used (expert consensus, 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 submission focuses solely on demonstrating substantial equivalence to a predicate device (ProLite Pulsed Light System, K number 010928) based on its design, intended use (treatment of vascular lesions), and technical specifications (delivers pulsed light at 550 nanometers). It does not include any clinical performance data or studies.
§ 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.