← Product Code LZU · K991130 # FLEXPLUG (K991130) _Eagle Vision, Inc. · LZU · Apr 20, 1999 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K991130 ## Device Facts - **Applicant:** Eagle Vision, Inc. - **Product Code:** LZU - **Decision Date:** Apr 20, 1999 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** OP - **Attributes:** Therapeutic ## Intended Use The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye. ## Device Story FlexPlug Punctum Plug is a medical device designed for insertion into the punctum or canaliculus of the eye. It functions by occluding the tear drainage system to retain tears on the ocular surface. Used by ophthalmologists or optometrists in a clinical setting to treat chronic dry eye. By blocking tear drainage, the device increases tear film volume and residence time, potentially alleviating symptoms of dry eye and improving patient comfort. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Punctum plug device for mechanical occlusion of the tear drainage system. Specific materials and dimensions not detailed in the provided text. ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three horizontal lines above a wavy line. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 0 1999 Mr. C. Curtis Freeman President Eagle Vision, Inc. 6263 Poplar Ave, Suite 650 Memphis, TN 38119 Re: K991130 Trade Name: FlexPlug Punctum Plug Regulatory Class: II Product Code: 86 LZU Dated: April 1, 1999 Received: April 2, 1999 Dear Mr. Freeman: 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 . {1}------------------------------------------------ Page 2 - C. Curtis Freeman, President 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) 594-4613. 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, A Roerl lorentbal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for "EAGLEVISION Solutions for Better Vision". The logo features a stylized eye graphic to the left of the text "EAGLEVISION". Below "EAGLEVISION" is the text "Solutions for Better Vision". The text is in a simple, sans-serif font. ## Indications for Use Statement Page 1 of 1 510(k) Number (if known): _ L 99 1130 Device Name: FlexPlug Punctum Plug Indications for Use: The EagleVision FlexPlug Punctum Plug intended use is punctal and canalicular occlusion in patients with chronic dry eye. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Cathleen A. Boulware (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K991130 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use 6263 POPLAR AVENUE, SUITE 650 · MEMPHIS, TENNESSEE 38119 U S A 9 0 1 / 6 8 2 - 9 4 0 0 ・ F A X 9 0 1 / 7 6 1 - 5 7 3 6 ・ E - M A I L : e a g l e p l u g @ a o l . c o m --- **Source:** [https://fda.innolitics.com/device/K991130](https://fda.innolitics.com/device/K991130) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com