Manufacturer
Iridex CorporationIRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K143154
- Device name
- IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
- Company
- Iridex Corporation
- 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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Not ingested
K143154 references 1 predicate/reference device
Cited as predicate
1IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
1 submission cite K143154 as a predicate
