Manufacturer
Lumenis, Inc.Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
Country / Region:Israel (IL)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
5Cited as predicate
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