FLEXPLUG

K991130 · Eagle Vision, Inc. · LZU · Apr 20, 1999 · OP

Device Facts

• Record ID: K991130
• Device Name: FLEXPLUG
• Applicant: Eagle Vision, Inc.
• Product Code: LZU · OP
• Decision Date: Apr 20, 1999
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• 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.

Indications for Use

Indicated for punctal and canalicular occlusion in patients with chronic dry eye.

Submission Summary (Full Text)

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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 .

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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

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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

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