← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K970422 # RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS (K970422) _Trimedyne, Inc. · GEX · Apr 21, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970422 ## Device Facts - **Applicant:** Trimedyne, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Apr 21, 1997 - **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 Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH). ## Device Story System consists of Optilase Nd:YAG laser energy sources and UroGold/UroMax right angle fiber optic delivery systems. Laser energy delivered via quartz fiber to target tissue; used for incision, excision, resection, vaporization, ablation, coagulation, and hemostasis. Specifically used for prostatectomy in BPH treatment. Operated by physicians in surgical settings. Output is continuous wave laser energy; clinical effect is thermal tissue destruction/coagulation. Higher power (60W) compared to previous 40W standard; intended to provide viable alternative to transurethral resection of the prostate (TURP). ## Clinical Evidence Limited clinical study evaluated Visual Laser Ablation of the Prostate (VLAP) at 60 watts. Data compared to historical study of 40-watt VLAP versus TURP. Results indicate 60-watt VLAP is a viable alternative to TURP. ## Technological Characteristics Continuous wave Nd:YAG laser system; 3-meter buffered quartz fiber delivery system; fiber optic connector; adjustable power output; aiming beam. ## 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 - [K954597](/device/K954597.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} APR 21 1997 # Trimedyne K970422 ## Summary of 510(k) Safety and Effectiveness Information Trimedyne® Right Angle Laser Fibers and Optilase® Lasers for the Treatment of BPH at 60 watts of Laser Power 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 92619-7001 714/559-5300 714/559-1330 Contact Person: Susan H. Gamble Director, Regulatory Affairs & Quality Assurance Summary Date: February 3, 1997 ### II. Device Name Proprietary: Optilase® Model 1000 Nd:YAG Laser System Optilase® Model 4000 Nd:YAG Laser System Optilase® PL100 Model 1000-100 Nd:YAG Laser System UroGold™ Right Angle Laser Fibers UroMax™ Right Angle Laser Fibers Additional proprietary names may be used for other Right Angle Laser Fiber configurations. Common: Laser-powered Instrument Laser Fiber Classification: Nd:YAG Laser System Accessory to Laser-powered Instrument - Not Classified ### III. Predicate Device The predicate devices are those cleared under 510(k) K954597. ### IV. Device Description The Optilase laser systems are continuous wave Nd:YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector. The Right Angle Laser Fibers are fiber optic Nd:YAG energy delivery systems consisting of: a three meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector. TRIMEDYNE, INC. 2801 BARRANCA ROAD, IRVINE, CA 92714 J:\FDA\510K\60WATT.BPH60WSUB.DOC 3-Feb-97 714 559-5300, FAX 714 559-1330 800 733-5273 {1} V. Intended Use The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH). VI. Technological Characteristics There are no technological differences between these devices and those cleared under K954597. VII. Nonclinical Tests No nonclinical tests were submitted in this Premarket Notification. VIII. Clinical Tests A limited clinical study was undertaken to provide information related to Visual Laser Ablation of the Prostate (VLAP) with 60 watts of laser power. These data were compared to data obtained from an earlier study in which VLAP at 40 watts of laser power was compared to TURP. IX. Conclusions Drawn from Testing The results of the comparative data submitted in this Premarket Notification demonstrate that VLAP, whether it be performed at 40 watt or 60 watt treatment parameters, is a viable alternative to TURP. J:FDA1510K160WATT.BPH160WSUB.DOC 3-Feb-97 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970422](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K970422) **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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