← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K954597 # RIGHT ANGLE LASER FIBERS (K954597) _Trimedyne, Inc. · GEX · Mar 11, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K954597 ## Device Facts - **Applicant:** Trimedyne, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Mar 11, 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 Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation, and hemostasis for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions. Viewing scopes, which can be either flexible or rigid, may be used for visualization during laser procedures. ## Device Story System comprises Right Angle Laser Fiber (3m buffered quartz fiber, tip, connector) and Optilase Nd:YAG laser (continuous-wave source, aiming beam, adjustable power). Used in urological surgery; operated by physicians. Laser energy delivered via fiber through flexible or rigid viewing scopes to prostate tissue. Enables incision, excision, resection, vaporization, ablation, coagulation, and hemostasis. Clinical benefit: minimally invasive treatment of BPH compared to traditional resection. ## Clinical Evidence Prospective, controlled, well-matched study comparing visual laser ablation of the prostate (VLAP) using the subject devices to transurethral resection of the prostate (TURP). Data concluded the devices are safe and effective for BPH treatment. ## Technological Characteristics Continuous-wave Nd:YAG laser system; 3-meter buffered quartz fiber optic delivery; aiming beam; adjustable power output; fiber optic connector interface. ## 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 - Trimedyne Right Angle Laser Fiber ([K944204](/device/K944204.md)) - Trimedyne Optilase Nd:YAG Laser Systems ([K922497](/device/K922497.md)) - Trimedyne Optilase Nd:YAG Laser Systems ([K932883](/device/K932883.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} k954597 Trimedyne MAR 11 1996 # Summary of 510(k) Safety and Effectiveness Information ## Trimedyne® Right Angle Laser Fibers and ## Optilase® Nd:YAG Laser System Models 1000, 4000, and 1000-100 (PL100) This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ### I. Submitter Information: Trimedyne, Inc. P.O. Box 57001 Irvine, CA 92719-7001 714/559-5300 714/559-1330 (facsimile) Contact Person: Susan H. Gamble Director, Regulatory Affairs & Quality Assurance Summary Date: October 2, 1995 ### II. Device Name Right Angle Laser Fibers: Proprietary: Not yet selected Common: Laser fiber Classification: Accessory to Laser-powered Instrument (unclassified) Optilase Lasers: Proprietary: - Optilase® Model 1000 Nd:YAG Laser System - Optilase® Model 4000 Nd:YAG Laser System - Optilase® PL100 Model 1000-100 Nd:YAG Laser System Common: Neodymium Yttrium Aluminum Garnet (Nd:YAG) laser system Classification: Laser-powered Instrument ### III. Predicate Device The predicate devices for the intended use are various configurations of the Trimedyne Right Angle Laser Fiber cleared under 510(k) number K944204 and the Trimedyne Optilase Nd:YAG Laser Systems cleared under 510(k) numbers K922497 and K932883. TRIMEDYNE, INC. 2801 BARRANCA ROAD P.O. BOX 57001, IRVINE, CA 92619-7001 714 559-5300, FAX 714 559-1330 800 33 5271 {1} ## IV. Device Description The Right Angle Laser Fiber is a fiber optic Nd:YAG energy delivery system consisting of: a 3 meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector. The Optilase laser systems are continuous-wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector. ## V. Intended Use The Right Angle Laser Fiber and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation, and hemostasis for the treatment of benign prostatic hyperplasia (BPH) and other urological conditions. Viewing scopes, which can be either flexible or rigid, may be used for visualization during laser procedures. ## VI. Technological Characteristics There are no technological characteristics differences between the devices cleared under this 510(k) and the predicate devices with regard to the intended use. ## VII. Nonclinical Tests No nonclinical tests were submitted in this Premarket Notification. ## VIII. Clinical Tests A prospective, controlled and well-matched study was undertaken to compare visual laser ablation of the prostate (VLAP) to transurethral resection of the prostate (TURP). ## IX. Conclusions Drawn from Testing The clinical data show that the Trimedyne Right Angle Laser Fibers and Optilase Nd:YAG Laser Systems are safe and effective for treatment of Benign Prostatic Hyperplasia (BPH). --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K954597](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K954597) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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