# K060338: Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta  Duet, Selecta Duo, Selecta Trio

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Inc.
- Decided: Mar 9, 2006 after 27 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894841 (1989). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051944: Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo), Delivery Device and Accessories, Lumenis, Inc. (2005) Summary page 1.

## Indications for use
Selecta 1064: photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy Selecta SLT: selective laser trabeculoplasty Selecta Duet: photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and selective laser trabeculoplasty LaserLink S: laser delivery system for use by an ophthalmologist in the treatment of ocular tissue; laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section. The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically, An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment. Selecta Duo: same indications for use as a Selecta 1064® and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator Selecta Trio: same indications for use as a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator

Source page: https://510kreport.com/device/K060338
Methodology: https://510kreport.com/methodology