# K081704: Selecta Family of Ophithalmic Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Sep 11, 2008 after 86 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: 3 generations back to K894841 (1989). 13 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 23 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.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 3.

## Cited in the summary but kept off the family tree
- K097340: Coherent Popeye Ophthalmic Laser System (EPIC I and EPIC IV). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K130933: Solutis (2013), 4 descendants of its own
- K140336: Optimus Fusion: SLT, Yag and Yag/SLT (2014), 3 descendants of its own
- K220877: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (2022), 2 descendants of its own
- K230722: Eagle device (2023), 1 descendant of its own
- K192045: Ophthalmic Yag Laser System YC-200 (2019), 1 descendant of its own

## Indications for use
The Indications for use for the Selecta Family of Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duet, LaserLink S, Selecta Duo, and Selecta Trio) and Accessories are as follows: Selecta 1064: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discussion 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. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section. 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 aphakic and pseudophakic patients, and iridotomy/iridectomy and retinal photocoagulation. Selecta Trio: 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, retinal photocoagulation and selective laser trabeculoplasty.

Source page: https://510kreport.com/device/K081704
Methodology: https://510kreport.com/methodology