(266 days)
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :
· Benign vascular lesions and vascular dependent lesions removal
The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
The provided text describes a medical device, a Laser Treatment System, and its substantial equivalence to a predicate device for FDA clearance. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria from a clinical performance perspective.
The document focuses on:
- Regulatory Clearance (K211722): This is an FDA 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device, not necessarily clinical efficacy.
- Device Description and Intended Use: The device is a "Laser Treatment System" for "Benign vascular lesions and vascular dependent lesions removal."
- Comparison to Predicate Device (K172193): The comparison table highlights technological characteristics like product code, regulation number, indications for use, laser classification, wavelength, frequency, pulse duration, and compliance with various safety and biocompatibility standards.
- Performance Data (Non-Clinical):
- Biocompatibility Testing: Evaluated according to ISO 10993-1, covering Cytotoxicity, Irritation, and Sensitization. All acceptance criteria for these biocompatibility tests were met.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested to comply with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and the study proving it, as this information is not present in the provided text.
If this were a clinical study, the requested information would typically look something like this (hypothetical example, as the data is missing):
Hypothetical Acceptance Criteria and Performance (Based on common laser efficacy studies, NOT from the provided text)
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Hypothetical) |
|---|---|---|
| Clinical Clearance | ≥ 75% average lesion clearance after X treatments | 82% average lesion clearance |
| Adverse Event Rate |
§ 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.