# K162416: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

- Pathway: 510(k) (Special)
- Applicant: Iridex Corporation
- Decided: Sep 29, 2016 after 30 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: 2 generations back to K071687 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143154: IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID), Iridex Corporation (2015) Summary page 4.

## Most influential descendants
- K213592: Iridex 810 Laser (2022), 0 descendants of its own

## Indications for use
The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 810nm (The IRIDEX Cyclo G6 Laser System) Ophthalmology: 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: MicroPulse P3 Device: For the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, Refractory. Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. µP G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, Refractory. Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. CW

Source page: https://510kreport.com/device/K162416
Methodology: https://510kreport.com/methodology