(214 days)
The PL-1 Skin Treatment System is a 1064 nm laser system intended to ablate, vaporize, and coagulate soft body tissues for aesthetic and cosmetic applications in the medical specialties of dermatology and plastic surgery. It is also indicated for removal of benign pigmented lesions including; nevus of Ota, café au lait spot, ephelides, solar lentigines), Becker's nevus, nevus spilus and treatment of common nevi..
The PL-1 Skin Treatment System is intended to be used by medical professionals and staff who are of lasers and who are familiar with the technology, operation of the system, and safety precautions.
The PL-1 Skin Treatment System is a 1064nm, Q-switched laser system. The system includes three (3) main components: Console, Tablet, and Handpiece. The Console houses the system control electronics, power distribution, contact cooling, and laser. The primary user interface for controlling the system through a touch screen graphical user interface. The Handpiece contains the optics, focusing components, and reference window assembly.
The PL-1 Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Handpiece on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.
The provided regulatory document (K213726) for the PL-1 Skin Treatment System focuses on demonstrating substantial equivalence to a predicate device (Quanta Chrome, K202503) rather than presenting a clinical study where the device performance is measured against specific acceptance criteria.
The document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/algorithm-driven device with ground truth establishment, expert adjudication, or MRMC studies.
Instead, it asserts substantial equivalence based on:
- Same intended use and similar indications for use.
- Similar technological characteristics and operating principles (e.g., laser type, wavelength, mechanism of action, focused microbeams).
- Performance testing for safety and basic functionality compliant with established standards, such as electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software life cycle processes (IEC 62304), usability (IEC 60601-1-6, IEC 62366-1), and laser specific safety (IEC 60601-2-22, IEC 60825-1).
- Biocompatibility (ISO 10993-1).
The document explicitly states: "Animal studies and clinical performance testing were not deemed necessary as the device is using the same key technology, operating principles, and intended use as the predicate device." This indicates that a study with the characteristics typically seen for AI/algorithm-driven medical devices (like those requiring test sets, expert ground truth, MRMC studies) was not conducted for this 510(k) submission.
Therefore, I cannot provide a table of acceptance criteria and proven device performance, nor can I answer points 2 through 9, as this information is not present in the provided text. The submission relied on demonstrating technological equivalence and compliance with relevant safety and performance standards for a laser device, not on clinical performance metrics with a test set and associated ground truth.
§ 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.