# K143154: IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)

- Pathway: 510(k) (Special)
- Applicant: Iridex Corporation
- Decided: Jan 2, 2015 after 60 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: 1 generation back to K071687 (2008). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 4.

## Most influential descendants
- K162416: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate (2016), 1 descendant of its own
- K213592: Iridex 810 Laser (2022), 0 descendants of its own
- K163632: Katalyst Cyclophotocoagulation Probe (2017), 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 (IRIDEX Cyclo G6 Laser System) Ophthalmology: The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & 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. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. CW/µP: µP. G-Probe: For the treatment of Glaucoma including: Primary Open-Angle, Closed-Angle, Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. CW/µP: CW.

Source page: https://510kreport.com/device/K143154
Methodology: https://510kreport.com/methodology