(88 days)
As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxillofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.
Not Found
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary and FDA clearance letter for a medical device (CLR 2940 Erbium CrystaLase).
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Continuum Biomedical CB Erbium/2.94), rather than presenting a performance study against predefined acceptance criteria. The clearance letter confirms that the device is substantially equivalent to legally marketed devices based on the indications for use.
Therefore, I cannot populate the requested tables and information as no such details are present in the provided text. The document states: "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns," which is a statement of belief for substantial equivalence, not a report of a study against acceptance criteria.
§ 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.