← Product Code [GEX](/productcode/GEX) · K965180 # STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) (K965180) _Myriad Lase, Inc. · GEX · Jun 5, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K965180 ## Device Facts - **Applicant:** Myriad Lase, Inc. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Jun 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery. ## Device Story SträteFire™ Reusable Optical Fibers are fiberoptic laser delivery systems designed for use with surgical laser equipment. The device consists of a fused silica optical fiber (400, 600, 800, or 1,000 micron diameter) with a proximal SMA-905 connector. It transmits laser energy (wavelengths 532–1400 nm) from a medical laser to the surgical site. Used by physicians in clinical settings for tissue ablation and hemostasis. Fibers are supplied sterile and are reusable following specified cleaning and sterilization protocols. ## Clinical Evidence Bench testing only. Optical performance testing demonstrated performance comparable to the predicate SideFire™ - Tipped Optical Fiber. ## Technological Characteristics Fused silica optical fiber; 400, 600, 800, or 1,000 micron diameters; proximal SMA-905 connector; compatible with surgical lasers operating at 532–1400 nm; supplied sterile in heat-sealed Tyvek; reusable; sterilization required per labeling. ## 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 - SideFire™ - Tipped Optical Fibers, MyriadLase, Inc. ([K920553](/device/K920553.md)) - SideFire™ - Tipped Reusable Optical Fibers, MyriadLase, Inc. ([K952733](/device/K952733.md)) - Laserguide Surgi Light Optical Fibers, Surgimedics ([K914396](/device/K914396.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} JUN - 5 1997 K965180 # 510 (k) SUMMARY ## I. ADMINISTRATIVE Submitter: MyriadLase, Inc. 1315 FM 1187 Mansfield, Texas 76063 817-477-2041 Contact Person: Dr. Royice Everett Date of Preparation: April 18, 1997 ## II. DEVICE NAME Proprietary Name: SträteFire™ Reusable Optical Fibers Common Name: Reusable Laser Fiber Classification Name: Fiberoptic Laser Delivery System ## III. PREDICATE DEVICES SideFire™ - Tipped Optical Fibers, MyriadLase, Inc.; K920553 SideFire™ - Tipped Reusable Optical Fibers, MyriadLase, Inc.; K952733 Laserguide Surgi Light Optical Fibers, Surgimedics; K914396 ## IV. DEVICE DESCRIPTION The SträteFire™ Reusable Optical Fiber is a fiberoptic laser energy delivery system intended for use with any surgical laser equipment fitted with SMA-905 compatible connectors and designed to operate at wavelengths between 532 and 1400 nm. The SträteFire™ Reusable Optical Fiber consists of a 400, 600, 800 or 1,000 micron diameter fused silica optical fiber with a proximal SMA-905 connector for attaching to a medical laser. Fibers are supplied sterile in heat-sealed Tyvek and may be reused after cleaning and sterilization as directed in the labeling. ## V. INTENDED USE Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery. ## VI. COMPARISON TO PREDICATE DEVICES The SträteFire™ Reusable Optical Fibers are similar in design, and identical in function and intended use, to other laser optical fibers, such as the MyriadLase SideFire™ - Tipped Optical Fibers (K920553) and SideFire™ - Tipped Reusable Optical Fibers (K952733), and Surgimedics Laserguide™ Surgi Light Optical Fibers, K965180 Amendment 10 {1} (K914396). Optical performance testing has demonstrated comparable performance of the to the SideFire™ - Tipped Optical Fiber. Accordingly, MyriadLase, Inc., concluded that the StrateFire™ Reusable Optical Fibers are safe and effective for their intended use and perform at least as well as legally marketed predicate devices, such as the SideFire™ - Tipped Optical Fibers, SideFire™ - Tipped Reusable Optical Fibers, and Surgimedics Laserguide® Surgi Light Optical Fibers. K965180 Amendment {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 5 1997 MyriadLase, Inc. c/o Mr. Richard A. Hamer Richard Hamer Associates, Inc. PO Box 16598 Ft. Worth, Texas 76162-0958 Re: K965180 Trade Name: Stratefire™ Reusable Optical Fibers Regulatory Class: II Product Code: GEX Dated: April 18, 1997 Received: April 21, 1997 Dear Mr. Hamer: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3} Page 2 - Mr. Richard A. Hamer This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} Page 1 of 1 510(k) Number (if known): K965180 Service Name: **STRATEFIRE** StraightFire™ Reusable Optical Fibers ## Indications for Use: Ablation and hemostasis in treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![img-1.jpeg](img-1.jpeg) Prescription Use ☑ (Per 21 CFR 801.109) OR Over-the-Counter Use ☐ (Optional Format 1-2-96) Premarket Notification: StraightFire™ Reusable Optical Fibers --- **Source:** [https://fda.innolitics.com/device/K965180](https://fda.innolitics.com/device/K965180) **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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