← Product Code [HQF](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF) · K050807 # 20G SMA LASER FIBER, MODEL LF100 (K050807) _Ophthalmed, LLC · HQF · Sep 21, 2005 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K050807 ## Device Facts - **Applicant:** Ophthalmed, LLC - **Product Code:** [HQF](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF.md) - **Decision Date:** Sep 21, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4390 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use For use to perform endo-ocular laser photocoagulation treatments, with illumination, aspiration and backwash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm ## Device Story The LF100 is a 20G ophthalmic surgical probe combining laser delivery, illumination, and aspiration/back-wash capabilities. It features a handpiece with a 20G extension, an 8 ft fiberoptic cable, and connectors for laser and illumination sources, plus a Luer lock for connection to a vitrectomy machine. The device is used by ophthalmologists in a surgical setting to facilitate intraocular procedures. The laser fiber provides photocoagulation, the illumination fiber provides visualization of the surgical site, and the aspiration/back-wash tube allows for fluid management. By integrating these functions into a single probe, the device simplifies the surgical workflow, potentially reducing procedure time and improving surgical access within the eye. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics 20G ophthalmic probe; includes fiberoptics for laser (500-1100 nm) and illumination, and a tube for aspiration/back-wash. Handpiece with 8 ft fiber length. Sterilized via Ethylene Oxide. No electrical, thermal, or radiation components integral to the probe function. ## 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 - 20g and 25g SMA Laser Fibers, Model LF20 and LF25 ([K021696](/device/K021696.md)) - [K982462](/device/K982462.md) - [K946135](/device/K946135.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}------------------------------------------------ # SEP 2 1 2005 # K050807 # 510(k) Summary As Required by 21 section 807.92 ( c ) 1-Submitter Name: OphthalMed LLC 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA (678) 908- 8180 3-Phone: (678) 623- 3765 4-Fax: 5-Contact Person: Jay Mansour 6-Date summary prepared: July 14th, 2005 7-Device Trade or Proprietary Name: 20g SMA Laser/Illumination/Aspiration/Back-wash probes. Model LF100 8-Device Common or usual name: (1) Ophthalmic laser, (2) Endoillumination probe and (3) vitreous aspiration (1) Ophthalmic laser, (2) Light, surgical, fiberoptic and 9-Device Classification Name: (3) Instrument, vitrous aspiration and cutting 10-Substantial Equivalency is claimed against the following device: 20g and 25g SMA Laser Fibers, Model LF20 and LF25 from OPHTHALMED LLC (510k #K021696), as well as 510k #K982462 and K946135. ### 11-Description of the Device: This device consists of the following parts already connected to each other: - Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye. - 8 ft fiber. - A special connector that attaches the laser fiberoptic end to the laser source. - A special connector that attaches the illumination fiberoptic end to the illumination source - Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine - A flexible plastic jacket covers the length of the fiberoptics and tubes. Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation. #### 12-Intended use of the device: For use to perform endo-ocular laser photocoagulation treatments, with illumination, aspiration and backwash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm ### 13-Safety and Effectiveness of the device: This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below) ## 14-Summary comparing technological characteristics with other predicate device: {1}------------------------------------------------ Please find below a tabulated comparison supporting that this device is substantially equivalent and submit and the supportion distribution I fease find before a laes in commercial distribution. | FDA file reference
number | TECHNOLOGICAL
CHARACTERISTICS | 510k #K021696 for
laser
Comparison result | 510k #K982462 for
illumination
Comparison result | 510k #K946135 for
aspiration/back-wash
Comparison result | |--------------------------------------------------------|----------------------------------|-------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------| | Indications for use | Identical | Identical | Identical | | | Target population | Identical | Identical | Identical | | | Design | Similar | Similar | Similar | | | Materials | Similar | Similar | Similar | | | Performance | Similar | Similar | Similar | | | Sterility | Similar (Ethylene
Oxide) | Similar (Ethylene Oxide) | Similar (Ethylene Oxide) | | | Biocompatibility | Similar | Identical | Identical | | | Mechanical safety | Similar | Similar | Similar | | | Chemical safety | Similar | Similar | Similar | | | Anatomical sites | Identical | Identical | Identical | | | Human factors | Identical | Identical | Identical | | | Energy used and/or
delivered | Identical | Similar | Similar | | | Compatibility with
environment and other
devices | Identical | Identical | Identical | | | Where used | Identical | Identical | Identical | | | Standards met | Identical | Identical | Identical | | | Electrical safety | Identical (not
applicable) | Identical (not applicable) | Identical (not applicable) | | | Thermal safety | Identical (not
applicable) | Identical (not applicable) | Identical (not applicable) | | | Radiation safety | Identical (not
applicable) | Identical (not applicable) | Identical (not applicable) | | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. SEP 2 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OphthalMed LLC c/o Mr. Jay Mansour Director, QA and Regulatory Affairs 1308 Morningside Park Dr. Alpharetta, GA 30022 Re: K050807 KU50807 Trade/Device Name: OphthalMed 20G SMA Laser/Illumination/Aspiration/A Back-wash probe, Model LF100 Regulation Number: 21 CFR 886.4390 Regulation: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: August 31, 2005 Received: September 1, 2005 Dear Mr. Mansour: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premaintly equivalent (for the indications referenced above and have determined the device is substantially interstate referenced above and nave determined the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced promotions of the Federal Food. Device American Food. Drug commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reculted in accordance with as proval approval application (PMA). and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The Act. The You may, therefore, market the device, subject to the gener You may, therefore, market the device, subject to annual registration, listing of general controls provisions of the Act include requirements michronding and general controls provisions of the net network of the measure misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) the existing major regulations affecting your device and may be subject to such additional controlls. Existing may of to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Ingerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a backers on the other requirements of the Act that FDA has made a determination that your device complies with other must that FDA has made a decernmanon that Jour access as agencies. You must of of any Federal statutes and regulations as including, but not limited to: registration and listing comply with all the Act 3 requirements, meaths, good manufacturing practice requirements as set (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the ologtrop (2) CFR Part 807); labelling (21 CFR Part 820); good art 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Party 11 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2- Mr. Jay Mansour This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nothication. The PDA miding of bassification 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), please s antiled If you desire specific advice for your don'ter at (301) 827-8910. Also, please note the regulation entitled, contact the Office of Compliance at (301) 827-8910. Also, pleas contact the Office of Complance at (501) 627 627 627 67 67 807.97). You may obtain " Misbranding by relectice to premance notifical varies and er the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanter : 15566777 or and industry/support/index.html. Sincerely yours, David M. Whipple David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K050807 Device Name: Laser/Illumination/Aspiration/Back-wash probe, LF100 Indications For Use: For use to perform endo-ocular laser photocoaguation treatments, with illumination, the sub-For use to perform endo-ocular laser photocoaguation area.home, while havelength is 500nm aspiration and back-wash during surgical interventions. The operating wavelength is to 1,100nm. V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use __ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) C. C. Claussen (Division Sign-Off) Division of Ophthalmic Ear Division of Ophthalmic Ear, Nose and Throat Devises K050807 510(k) Number _ Page 1 of ____________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K050807](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K050807) **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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