OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450

K053475 · Refractec, Inc. · HMR · Mar 3, 2006 · Ophthalmic

Device Facts

• Record ID: K053475
• Device Name: OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
• Applicant: Refractec, Inc.
• Product Code: HMR · Ophthalmic
• Decision Date: Mar 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4570
• Device Class: Class 1

Intended Use

The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for subsequent ophthalmic surgical manipulation.

Device Story

The OptiPoint Corneal Template is a manual surgical instrument used by ophthalmologists during eye surgery. It functions as a physical template or guide placed on the cornea to facilitate the precise application of markings using a separate, legally marketed skin marker. These markings serve as visual references for the surgeon to guide subsequent surgical manipulation. The device is used in a clinical or surgical setting to improve the accuracy of site localization on the cornea, thereby aiding the surgeon in performing ophthalmic procedures.

Clinical Evidence

Bench testing only; no clinical data required for this class of manual surgical instrument.

Technological Characteristics

Manual ophthalmic surgical template. Form factor designed for corneal application. Non-powered, standalone device. Materials and sterilization methods consistent with standard ophthalmic surgical instruments.

Indications for Use

Indicated for use as a corneal marking guide to assist in the localization of sites for ophthalmic surgical procedures.

Regulatory Classification

Identification

An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 2006

Refractec, Inc. c/o Gary Mocnik V.P. Regulatory Affairs 5 Jenner, Suite 150 Irvine, CA 92618

Re: K053475

Trade/Device Name: OptiPoint Corneal Template Regulation Number: 21 CFR 886.4570 Regulation Name: Ophthalmic Surgical Marker Regulatory Class: Class I Product Code: HMR; HMQ Dated: December 14, 2005 Received: January 4, 2006

Dear Mr. Mocnik:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreated 776, 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Gary Mocnik

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

BEpleluns, uns

Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K053475

Device Name: OptiPoint Corneal Template

Indication For Use:

The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for wind regally subsequent ophthalmic surgical manipulation.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Masha R. B Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear.
Nose and Throat Devises

510(k) Number K053475

Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter Use