MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB

K022982 · Med-Logics, Inc. · HNO · Nov 15, 2002 · Ophthalmic

Device Facts

• Record ID: K022982
• Device Name: MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
• Applicant: Med-Logics, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Nov 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Med-Logics 7050CLB microkeratome blades are to be used, as replacement blades for the Moria M2™ microkeratome, to perform lamellar keratectomy procedures.

Device Story

The Med-Logics 7050CLB is a replacement microkeratome blade designed for use with the Moria M2 microkeratome system. It functions as a mechanical cutting instrument during lamellar keratectomy procedures. The device is intended for use by ophthalmic surgeons in a clinical or surgical setting. By providing a sharp, compatible cutting edge for the existing microkeratome, the blade facilitates the creation of corneal flaps required for refractive surgery. The device is a single-use component that replaces worn blades to ensure consistent surgical performance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical microkeratome blade; stainless steel construction; designed for compatibility with Moria M2 microkeratome system; single-use; non-powered.

Indications for Use

Indicated for patients undergoing lamellar keratectomy procedures using the Moria M2 microkeratome system.

Regulatory Classification

Identification

A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

Predicate Devices

• Moria M2 microkeratome (pre-amendment status)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 5 2002

Med-Logics. Inc. c/o Mr. Mark Moyer Vice President 26061 Merit Circle, Suite #102 Laguna Hills, CA 92653

Re: K022982

Trade/Device Name: Med-Logics Microkeratome Blade, Model 7050CLB Regulation Number: 21CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: September 6, 2002 Received: September 9, 2002

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 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) 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 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.

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## Page 2 – Mr. Mark Moyer

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlv/dsma/dsmamain.litml

Sincerely yours,

A. Ralph Rosenthal

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

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| 510(k) Notification | | | |
|----------------------------------------------------|------------------------------------|---------------|--|
| | Model 7050CLB™ Microkeratome Blade | Page 4 | |
| <img alt="MED-LOGICS" src="image.png"/> MED-LOGICS | PNS 500-0103 | File Document | |

INDICATIONS FOR USE FORM

| 510(k) number (if known): | K022982 |
|---------------------------|---------------------|
| Device Name: | Microkeratome Blade |

Indications for Use:

The Med-Logics 7050CLB microkeratome blades are to be used, as replacement blades for the Moria M2™ microkeratome, to perform lamellar keratectomy procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> | 11-14-02 |
|---------------|-------------------------------------------------------------------------|----------|
| | (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K022982 | |

| Prescription Use<br>Per 21 CFR 801.109 | <img alt="Prescription" src="prescription.png"/> | OR | Over-the-Counter Use<br>(Optional Format 1-2-96) |
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For Use By Affiliates Of Med-Logics, Inc.

For Use By Affiliates Of Med-Logics, Inc.

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