(88 days)
The Liftendo 2.0 and Liftendo are intended for the delivery of laser light to soft tissue in contact mode and non-contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is also indicated for laser-assisted lipolysis. The device's 1470nm laser is intended for the delivery of laser light to soft tissue in non-contact mode during general surgical procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Liftendo 2.0 and Liftendo are intended for the delivery of laser light to soft tissue in contact mode and non-contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is also indicated for laser-assisted lipolysis. The device's 1470nm laser is intended for the delivery of laser light to soft tissue in non-contact mode during general surgical procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The provided text is a 510(k) summary for the Liftendo and Liftendo 2.0 laser surgical instruments. It does not contain information related to software or AI/ML device performance or the specific criteria requested for evaluating such a device.
The document focuses on demonstrating substantial equivalence to a predicate device (Triangel Rsd Limited's Diode laser therapy device, K212734) based on:
- Indications for Use: Nearly identical.
- Technological Characteristics: Same wavelength, output power max, aiming beam, treatment mode, cooling, and standards compliance (IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2).
- Non-clinical Testing: Compliance with IEC 60601-2-22, IEC 60601-1, and IEC 60601-1-2 standards for safety and performance (e.g., electrical safety, EMC).
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies for an AI/ML diagnostic device, as these details are not present in the provided text. The document describes a traditional medical device (laser surgical instrument) and its comparison to a predicate, not an AI/ML-driven clinical support or diagnostic tool.
§ 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.