← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K962592 # OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS (K962592) _Alcon Laboratories · GEX · Sep 23, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962592 ## Device Facts - **Applicant:** Alcon Laboratories - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Sep 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty. ## Device Story Ophthalas 532 is a pulsed solid-state frequency-doubled Nd:YAG laser; produces 532 nm green therapeutic beam via harmonic generation through non-linear optical crystal; includes 633 nm HeNe aiming beam and 1064 nm infrared beam. Used in ophthalmic surgery by physicians to create thermal lesions. Operates similarly to conventional Argon lasers for retinal/macular photocoagulation, cyclophotocoagulation, sclerostomy, iridotomy, and trabeculoplasty. Provides precise thermal tissue effects for ocular treatment. ## Clinical Evidence Bench testing only; performance data demonstrates the device consistently and safely produces thermal lesions equivalent to those produced by conventional Argon lasers. ## Technological Characteristics Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser; frequency-doubled to 532 nm green beam; 633 nm HeNe aiming beam; 1064 nm infrared beam. Uses non-linear optical dielectric crystal for harmonic generation. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - Ophthalas 532 Photocoagulator (Alcon Laboratories) - Blue-green Argon Ophthalmic Lasers ## 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} SEP 23 1996 K962592 Alcon LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TX 76134 (817) 551-8388 May 14, 1996 510(K) SUMMARY Submitted by: Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax) Trade Name: Ophthalas® 532 Solid State Photocoagulator Common Name: Solid state ophthalmic laser photocoagulator Classification Name: Ophthalmic Laser (per 21 CFR 886.4390) {1} K962592 # 1. Predicate Device The legally marketed device(s) to which we are claiming equivalence to are the Ophthalas® 532 Photocoagulator marketed by Alcon Laboratories, and blue-green Argon Ophthalmic Lasers cleared for the Trabeculoplasty indication. # 2. Device Description The Ophthalas 532 Solid State Photocoagulator, and/or equivalent devices, are a pulsed solid state frequency doubled Nd:YAG laser producing a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam. A 633 nm helium-neon (HeNe) laser is used for the aiming beam source. # 3. Intended Use of the Device The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty. # 4. Summary of the Technological Characteristics of the Device The Ophthalas 532 is a Neodymium-doped Yttrium Aluminum Garnet type laser which has been designed for ophthalmic use. LASER is an acronym for “Light Amplified by Stimulated Emission of Radiation.” This laser delivers a 532 nm green laser beam (frequency doubled), a 633 nm HeNe (Helium-Neon) aiming beam, and a 1064 nm infrared laser beam. The laser beam may be defined as a visible (i.e.; green 532 nm) or invisible (i.e.; 1064 nm), coherent monochromatic light beam. The doubling process of the 1064 wavelength results when the infrared beam goes through a special crystal. The crystal is an optical dielectric that exhibits a non-linear optical response. The 532nm wavelength is produced by harmonic generation of the 1064nm laser beam. # 5. Summary of the Performance Data The Ophthalas 532 Laser consistently and safely produces a thermal lesion equivalent to those produced by conventional Argon lasers. # 6. Conclusions The Ophthalas 532 Laser is substantially equivalent to Argon lasers for the treatment of all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962592](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962592) **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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