(90 days)
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or noncontact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery, and ophthalmology. This Ceralas D 980 is specifically indicated for laser assisted lipolysis.
The Ceralas D has the same technological characteristics as the cleared Ceralas and substantially similar technological characteristics as compared to the Quanta System Diode Medical Laser Family.
The information provided states that "No performance data is being submitted." for the Ceralas D 980nm Diode Laser System (Models D15, D25). Therefore, a detailed description of acceptance criteria and a study proving device performance cannot be extracted as this information is explicitly absent.
Instead, the submission relies on demonstrating "Substantial Equivalence" to predicate devices. The claim is that "The Ceralas D is as safe and effective as Biolitec's cleared Ceralas D 980nm Diode Laser (K072779) and the Quanta System Diode Medical Laser Family (K072034)." This equivalence is based on the new device having "the same intended uses and similar indications, technological characteristics, and principles of operation as the identified predicate devices, so there are no new issues of safety or effectiveness."
Thus, there is no study described in the provided text that defines acceptance criteria and proves the device meets them through 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.