IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

Iridex Corporation

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K162416
Device name
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-08-30
Decision date
2016-09-29
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cuttingVascular treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe, G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (µP) treatment mode and indicated for the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, and Refractory Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes.

Intended Use

The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe, G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (µP) treatment mode and indicated for the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, and Refractory Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes.

Device Description

The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components: Main console containing the major electrical components, including: Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display; Two delivery device fiber-optic connector ports (only one active at a time); LIO illumination connection; Smart key port for detecting/operating safety filters and/or accessory identification; Emergency stop switch; Key switch; Connector ports for the footswitch, remote control, and power cord; A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); A Wired Remote Control that duplicates the control panel; Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the G-Probe Illuminate. The G-Probe Illuminate is a handheld fiber optic delivery device intended to perform transscleral cyclophotocoagulation of the ciliary processes, differentiated by the incorporation of two additional optical fibers for white light transillumination of the optic globe.

Summary parsed at:2026-06-01 06:06:58 UTC

Predicate devices

1

K162416 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K162416 as a predicate