LUMENIS SELECTA DUET

• K Number: K021550
• Device Name: LUMENIS SELECTA DUET
• Manufacturer: Ellex Medical Pty. Ltd.
• Date Cleared: 2002-08-09 ( 88 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

CAPSULOTOMY
POSTERIOR IRIDOTOMY / IRIDECTOMY
POSTERIOR MEMBRANECTOMY
SELECTIVE LASER TRABELULOPLASTY (SLT)

Device Description

Not Found

AI/ML Overview

This document is a FDA 510(k) substantial equivalence determination letter for the Lumenis Selecta Duet. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, but it does not provide performance data, study design, or ground truth information.

Therefore, I cannot extract the requested information from the provided text.

Regulation Number and Section

§ 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.