Manufacturer
Iridex CorporationIRIDEX Cyclo G6 Laser System, G-Probe Illuminate
Country / Region:United States (US)Submission type:Special
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
- K162416
- Device name
- IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
- Company
- Iridex Corporation
- 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
1IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
K162416 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K162416 as a predicate
