# K051944: Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo), Delivery Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Sep 30, 2005 after 74 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894841 (1989). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021550: Lumenis Selecta Duet, Ellex Medical Pty, Ltd. (2002) Summary page 1.
- K973470: Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in Combination with the Coherent Argons, Lumenis, Inc. (1997) Summary page 1.
- K004006: Selecta 7000 Frequency Doubled, Q-Switched ND:Yag Ophthalmic Laser, Lumenis, Inc. (2001) Summary page 1.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- K060338: Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta  Duet, Selecta Duo, Selecta Trio (2006), 0 descendants of its own

## 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 Duo: 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 aphaldc and pseudophakic patients, and iridotomy/iridectomy; and selective laser trabeculoplasty The Selecta 1064, Selecta SLT and Selecta Duo 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. 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.

Source page: https://510kreport.com/device/K051944
Methodology: https://510kreport.com/methodology