(114 days)
The LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (eLipo) is further indicated for laser-assisted lipolysis.
The LipoLite (eLipo) is a microprocessor-controlled 1064 nm Nd: YAG laser system. It is composed of the following main units: high voltage power supply, laser assembly, control panel and cooling unit. The LipoLite (eLipo) delivers pulsed energy to pre-determined anatomical areas via an optical fiber.
I am sorry, but the provided text describes a 510(k) submission for a laser surgical instrument (LipoLite/eLipo) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for software or AI/ML-based medical devices.
Therefore, I cannot extract the requested information regarding device performance, sample sizes, expert qualifications, ground truth, or comparative effectiveness studies. This type of information is not present in the provided context, which is primarily a regulatory clearance document for a hardware device, not an AI/ML device.
§ 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.