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

Iridex Corporation

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K143154
Device name
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2014-11-03
Decision date
2015-01-02
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Surgical cuttingVascular treatmentPigment treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulseTM or LongPulse TM 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: 532 nm Dermatology: • Pigmented Skin Lesions • Vascular Lesions Ear, Nose, and Throat (ENT)/ Otolaryngology: Otosclerotic Hearing loss and/or diseases of the inner ear: • Stapedectomy • Stapedotomy • Myringotomies • Lysis of Adhesions • Control of Bleeding • Removal of Acoustic Neuromas • Soft tissue Adhesion in Micro/Macro Otologic Procedures Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: • Retinal photocoagulation (RPC) for the treatment of o Diabetic retinopathy, including:  Nonproliferative retinopathy  Macular edema  Proliferative retinopathy o Retinal tears and detachments o Lattice degeneration o Age-related macular degeneration (AMD) o Retinopathy of prematurity o Sub-retinal (choroidal) neovascularization o Central and branch retinal vein occlusion • Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including o Primary open angle/Closed angle 577nm Dermatology: • Treatment of Vascular and pigmented lesions Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: • Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including : o proliferative and nonproliferative diabetic retinopathy; o choroidal neovascularization; o branch retinal vein occlusion; o age-related macular degeneration o retinal tears and detachments o retinopathy of prematurity • Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 810nm Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples: o Retinal photocoagulation for the treatment of: o Diabetic retinopathy, including:  Nonproliferative retinopathy  Macular edema  Proliferative retinopathy o Retinal Tears, Detachments and Holes o Lattice degeneration o Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) o Retinopathy of prematurity o Sub-retinal (choroidal) neovascularization o Central and Branch Retinal Vein Occlusion o Laser trabeculoplasty, Iidotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including: o Primary open angle o Closed angle o Refractory Glaucoma (recalcitrant/uncontrolled)

Intended Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulseTM or LongPulse TM 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: 532 nm Dermatology: Pigmented Skin Lesions, Vascular Lesions. Ear, Nose, and Throat (ENT)/ Otolaryngology: Otosclerotic Hearing loss and/or diseases of the inner ear: Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft tissue Adhesion in Micro/Macro Otologic Procedures. Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: Retinal photocoagulation (RPC) for the treatment of Diabetic retinopathy, including: Nonproliferative retinopathy, Macular edema, Proliferative retinopathy, Retinal tears and detachments, Lattice degeneration, Age-related macular degeneration (AMD), Retinopathy of prematurity, Sub-retinal (choroidal) neovascularization, Central and branch retinal vein occlusion. Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including Primary open angle/Closed angle.

Device Description

The Iridex Cyclo G6 is 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, Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family). Optional Cart/Stand.

Summary parsed at:2026-06-01 06:10:35 UTC

Predicate devices

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K143154 references 1 predicate/reference device

Cited as predicate

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