← Product Code [HQF](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF) · K960971 # OCULIGHT GL (K960971) _Iriderm Div. · HQF · Aug 28, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K960971 ## Device Facts - **Applicant:** Iriderm Div. - **Product Code:** [HQF](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF.md) - **Decision Date:** Aug 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4390 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist. ## Device Story Semiconductor-based laser photocoagulator console; delivers true continuous wave green laser light (532 nm) for retinal photocoagulation and laser trabeculoplasty. Input: infrared (808 nm) semiconductor diode laser energy converted to 532 nm green light; aiming beam provided by red (630-650 nm) semiconductor CW laser. Used in clinical settings by ophthalmologists. Operates via fiber-optic coupling to cleared delivery devices: slit lamp adapter, endophotocoagulation probes, and laser indirect ophthalmoscope. Output: controlled laser energy for tissue coagulation. Clinical benefit: enables precise ocular tissue treatment for retinal conditions and glaucoma management. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Semiconductor-based laser photocoagulator. Primary source: 808 nm infrared diode laser, wavelength-converted to 532 nm green output. Aiming beam: 630-650 nm red semiconductor CW laser. Delivery: fiber-optically coupled to slit lamp adapters, endoprobes, or indirect ophthalmoscopes. Energy: true continuous wave. Standalone console. ## Regulatory Identification An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. ## Predicate Devices - IRIS Medical OcuLight SL Laser Photocoagulator System ([K894841](/device/K894841.md)) - Coherent Novus 2000 Laser Photocoagulator system ([K913127](/device/K913127.md)) - Alcon Ophthalas 532 Laser Photocoagulator System ([K932062](/device/K932062.md)) ## Reference Devices - IRIS Slit Lamp Adapter ([K912918](/device/K912918.md)) - IRIS Slit Lamp Adapter ([K913430](/device/K913430.md)) - IRIS EndoProbe ([K894841](/device/K894841.md)) - IRIS Laser Indirect Ophthalmoscope ([K903288](/device/K903288.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} AUG 28 1996 K960971 510(k) Summary IRIS Medical Instruments, Inc. OcuLight GL Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Theodore A. Boutacoff IRIS Medical Instruments, Inc. 340 Pioneer Way Mountain View, CA 94041 415-962-8100 Contact Person: (same as above) Date Prepared: March 7,1996 Name of Device and Name/Address of Sponsor OcuLight GL IRIS Medical Instruments, Inc. 340 Pioneer Way Mountain View, CA 94041 Classification Name Ophthalmic Laser Photocoagulator CFR Section: 886.4390 Product Code: 86 HQF Predicate Devices The OcuLight GL Laser Photocoagulator system is substantially equivalent to other currently legally marketed laser photocoagulator devices including IRIS Medical OcuLight SL Laser Photocoagulator System (K894841), the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062). Page 1 {1} Page 2 # Intended Use The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist. # Technological Characteristics and Substantial Equivalence The OcuLight GL is a semiconductor-based laser photocoagulator console which delivers true continuous wave green laser light. The OcuLight GL uses infrared (808 nm) semiconductor diode laser light as the primary source of energy which is then wavelength converted to a visible green (532 nm) laser light for delivery to the patient's eye and treatment. A second visible red (630-650 nm) semiconductor CW laser is used for aiming. The OcuLight GL is substantially equivalent to other currently legally marketed laser photocoagulator devices including the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062); as well as the IRIS Medical OcuLight SL Laser Photocoagulator System (K894841). All of these predicate devices are indicated for retinal photocoagulation using slit lamp delivery, endophotocoagulation probes, and the laser indirect ophthalmoscope; and for laser trabeculoplasty using slit lamp delivery. The Coherent Novus 2000 uses an argon gas laser as the treatment laser. The colors of the treatment beam are blue (488 nm) and green (514 nm). A moving filter is used to restrict delivery of only green laser light when desired. Power delivered is true continuous wave. The color of the treatment beam for the Alcon Ophthalas 532 is green (532 nm). This beam is generated from a frequency-doubled Nd:YAG laser which is optically pumped by arc lamps and acousto-optically Q-switched. Power delivered is pulsed. The color of the treatment beam for the IRIS Medical OcuLight SL is infrared (810 nm). This beam is generated directly from a semiconductor laser diode. Power delivered is true continuous wave. # Device Description The OcuLight GL is a semiconductor-based ophthalmic laser photocoagulator which delivers true continuous wave green laser light. It will only be used in conjunction with three fiber optically coupled delivery devices which have received prior FDA-premarket clearance: the IRIS Slit Lamp Adapter (K912918 for retinal photocoagulation and K913430 for laser trabeculoplasty), the IRIS EndoProbe (K894841), and the IRIS Laser Indirect Ophthalmoscope (K903288). --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K960971](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K960971) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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