(89 days)
Venacure 1470 Pro is intended for use in the treatment of varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.
Not Found
This FDA clearance letter (K181632) for the VenaCure 1470 Pro does not contain specific acceptance criteria, performance data, or details about a study designed to prove the device meets acceptance criteria.
The document primarily focuses on:
- Confirming that the device has been reviewed and found substantially equivalent to legally marketed predicate devices.
- Outlining general regulatory requirements (registration, listing, GMP, labeling, etc.).
- Stating the intended use/indications for use of the VenaCure 1470 Pro.
For specific details on acceptance criteria and performance studies, one would typically need to consult the full 510(k) submission document, which is not provided here.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. The document itself is a regulatory clearance letter, not a clinical study report or a summary of performance data.
§ 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.