(84 days)
The Ceralas Fiber-Coupled 1470nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Added Indication for Use: Laser Assisted Lipolysis
The Ceralas 1470nm contains the same basic components as the cleared Ceralas 980nm family and substantially similar technologies to the cleared Quanta 980 and 1470nm families.
The provided text does not contain information about specific acceptance criteria or a study that evaluated the device's performance against such criteria for the added indication of Laser Assisted Lipolysis. Instead, this document is a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than primary clinical performance data.
Therefore, I cannot populate the table or answer the questions as requested, as the necessary information is not present in the given text.
The document indicates that the Ceralas 1470nm Diode Laser family is considered "as safe and effective for this additional Indication for Use as the Ceralas 980nm Family and the Quanta System 980nm & 1470nm laser family" based on having "the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices." This is a statement of substantial equivalence, not a report of a new performance study.
§ 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.