510(k) · Cleared
ClearedIRIDEX Cyclo G6 Laser System, G-Probe Illuminate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iridex Corporation · GEX Powered Laser Surgical Instrument
Cleared on Sep 29, 2016 as substantially equivalent to K143154 (Iridex Corporation, 2015) after a 30-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Sep 29, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071687 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK071687 Famili of Iridex IQ Laser SystemsIridex Corp · 2008
- 1 generation backK143154 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Iridex Corporation · 2015
- This deviceK162416 IRIDEX Cyclo G6 Laser System, G-Probe IlluminateIridex Corporation · 2016
- Descendant · cites it directly · 0 of its ownK213592 Iridex 810 LaserIridex Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K213592Iridex 810 LaserIridex Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071687 | Famili of Iridex IQ Laser Systems | Iridex Corp | 2008 | — |
| −1 | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID) | Iridex Corporation | 2015 | — |
| 0 (this device) | K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | Iridex Corporation | 2016 | — |
| +1 | K213592 | Iridex 810 Laser | Iridex Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID)Summary page 4…lo G6 Laser System with Illumination Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories III. Predicate Devices K143154 –Iridex Cyclo G6 Laser System IV. Product Description The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser com… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213592 | Iridex 810 Laser | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213592 (Iridex Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143154.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (170 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162416: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162416
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026