# K071687: Famili of Iridex IQ Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Aug 7, 2008 after 416 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
No predicates in its family tree.
38 later devices descend from it; 13 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IRIS Medical OcuLight TX: named in the summary without a submission number
- (no number) IRIS Medical IQ 810 Diode Laser: named in the summary without a submission number
- (no number) IRIS Medical OcuLight GL/GLx: named in the summary without a submission number
- (no number) Asclepion Meditec AG Laser System Yellow Star: named in the summary without a submission number
- (no number) Lumenis Novus Varia Ophthalmic Laser: named in the summary without a submission number
- (no number) IRIDEX OtoProbe: named in the summary without a submission number
- (no number) IRIDEX D'Amico/Peyman Fluted EndoProbe: named in the summary without a submission number
- (no number) Straight and Illuminating LaserProbes - Adjustable Intuitive: named in the summary without a submission number
- (no number) IRIDEX IRIS Medical G-Probe Handpieces: named in the summary without a submission number
- (no number) IRIDEX IRIS Medical DioPexy Probe Handpieces: named in the summary without a submission number
- (no number) IRIDEX Wireless Footswitch: named in the summary without a submission number

## Most influential descendants
- K091581: Supra 577.Y Laser (2009), 16 descendants of its own
- K111108: Pascal Streamline 577 (with Accessories) (2011), 15 descendants of its own
- K133486: Stellaris PC Vision Enhancement System (2014), 7 descendants of its own
- K121475: Txcell Scanning Laser Delivery System (2012), 6 descendants of its own
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser (2013), 5 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]) 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 Dermatologqy * Pigmented Skin Lesions . Vascular Lesions Ear, Nose, and Throat (ENT)/ Otolarynqolo-qy 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 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· - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration - retinal tears and detachments - retinopathy of prematurity * Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle Glaucoma 630 - 670nm 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: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration - retinal tears and detachments - retinopathy of prematurity * Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 810nm Ophthalmoloqgy Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples: * Retinal photocoagulation for the treatment of: > Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy > Retinal Tears, Detachments and Holes >Lattice degeneration >Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) > Retinopathy of prematurity > Sub-retinal (choroidal) neovascularization > Central and Branch Retinal Vein Occlusion · Laser trabeculoplasty, Iidotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including: Primary open angle Closed angle > Refractory Glaucoma (recalcitrant/uncontrolled)

Source page: https://510kreport.com/device/K071687
Methodology: https://510kreport.com/methodology