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

Lumenis, Inc.

Country / region:Israel (IL)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Lumenis, Inc.
Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

5
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K162837
Device name
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
Company
Lumenis, Inc.
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-10-11
Decision date
2017-02-28
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Vascular treatment
Primary application
Vascular treatment
Classification source
AI classified

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.

Intended 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.

Device Description

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 used in conjunction with a compatible Lumenis ophthalmic laser systems. The LIO illuminates and magnifies the fundus image for observation, and when connected to a Lumenis ophthalmic laser system, the laser aiming and treatment beams are precisely focused and delivered to the patient's eye through the LIO. The Smart LIO is a wireless headset worn on the physician's head and is used to treat patients in a supine position or who could not otherwise be treated using a standard slit lamp delivery system.

Summary parsed at:2026-06-01 05:59:03 UTC

Predicate devices

5

K162837 references 5 predicate/reference devices

Cited as predicate

0

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