# K162837: Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Feb 28, 2017 after 140 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 4.

## Indications for use
The Lumenis Smart Laser Indirect Ophthalmoscope (LIO) is a battery-powered optical instrument intended for the viewing of the posterior segment of the eye and to deliver laser energy for photocoagulation procedures on the peripheral retina of the eye (in conjunction with the use of a hand-held condensing lens). The Smart LIO is indicated for use in the following photocoagulation procedures: - Panretinal photocoagulation; - Segmental peripheral photocoagulation; - Retinopexy; and, - Pediatric retinal repairs (under general anesthesia). The Smart LIO is intended to work in conjunction with the following Lumenis laser systems in ophthalmic photocoagulation procedures: - Lumenis Novus Spectra Laser System; - Lumenis Vision One Laser System; and - Lumenis Smart532™ Laser System.

Source page: https://510kreport.com/device/K162837
Methodology: https://510kreport.com/methodology