(190 days)
The ACTION II Laser System is indicated for: coagulation, vaporization or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; keratoses; scar revision (including acne scars).
The ACTION II Laser System produces a pulsed beam of coherent near-infrared (2940 nm) light upon activation by a footswitch. The beam is then directed to the treatment zone by means of an articulated arm coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. An aiming beam is coincident with the 2940 nm main laser beam.
This document outlines the FDA's 510(k) clearance for the Lutronic ACTION II Laser System. The acceptance criteria and supporting study information are not applicable in the context of this FDA clearance letter, as this is a medical device and not an AI/ML powered device.
This document pertains to a medical laser system and its clearance by the FDA based on substantial equivalence to existing predicate devices. It does not involve AI/ML technology, thus the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or MRMC studies is not present.
The clearance is based on non-clinical performance data and a comparison to predicate devices, which is common for traditional medical devices. No clinical performance data was required for this 510(k) submission.
§ 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.