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FDA 510(k)

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

K-Number: K162416 · 2016-09-29

ApplicantIridex Corporation
Decision Date2016-09-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K162416. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Iridex Corporation. The 510(k) number is K162416.

When did IRIDEX Cyclo G6 Laser System, G-Probe Illuminate receive FDA 510(k) clearance?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate received FDA 510(k) clearance on 2016-09-29, under 510(k) number K162416.

Who is the listed applicant for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

The FDA 510(k) record lists Iridex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

The FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is GEX. This falls under the Gastroenterology category.

Other records listing Iridex Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)K213592Iridex 810 LaserK202760Iridex 810 LaserK181662Iridex TruFocus LIO PremiereK170718Iridex TruFocus LIO Premiere

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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