MED-LOGICS, MODEL ML7090

K033293 · Med-Logics, Inc. · HNO · Jan 13, 2004 · Ophthalmic

Device Facts

• Record ID: K033293
• Device Name: MED-LOGICS, MODEL ML7090
• Applicant: Med-Logics, Inc.
• Product Code: HNO · Ophthalmic
• Decision Date: Jan 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4370
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MED-LOGICS ML7090 microkeratome blades are to be used, as replacement blades for the AMO Amadeus TM Microkeratome, to perform lamellar keratectomy procedures.

Device Story

The ML7090 Microkeratome Blade is a replacement component for the AMO Amadeus Microkeratome system. It is used by ophthalmic surgeons during lamellar keratectomy procedures to create corneal flaps. The blade functions as a mechanical cutting instrument, physically interacting with corneal tissue to facilitate the surgical procedure. It is intended for clinical use in an operating room or surgical suite setting. The device provides the physical cutting edge required for the microkeratome to perform its intended surgical function, enabling the surgeon to execute precise corneal incisions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical microkeratome blade; replacement component for AMO Amadeus Microkeratome; stainless steel construction; sterile, single-use.

Indications for Use

Indicated for use as replacement blades for the AMO Amadeus Microkeratome to perform lamellar keratectomy procedures. Prescription use only.

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

• AMO Amadeus Microkeratome

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

JAN 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Med-Logics, Inc c/o Rod Ross, CEO 2601 Merit Circle Laguna Hills, CA 92653

Re: K033293

Trade/Device Namc: ML 7090 Microkeratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: October 10, 2003 Received: October 16, 2003

Dear Mr. Ross:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bected by agains is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) is the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic 71ct) that as novely subject to the general controls provisions of the Act. The T ou may, therefore, manel the Act include requirements for annual registration, listing of general condois providering practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it If your device is classimod (600 aboro) as Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affect may be subject to such additional controller Linksing in 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 docs not mcan Please be advised that 1 Dri- installios of wouldevice complies with other requirements of the Act that I DV has made a acterimmalations administered by other Federal agencies. You must or any I edelul statules and roginements, including, but not limited to: registration and listing Compry with an the Act 3 requirements, and 801); good manufacturing practice requirements as set (21 CFR Part 607), laboring (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Rod Ross, CEO

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/dsma/dsmamain.html

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

Enclosure

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| 510(k) Notification | | | |
|---------------------|----------------------------------|---------------|--|
| | MED-LOGICS, INC. | | |
| | Model ML7090 Microkeratome Blade | Page 4 | |
| | PNS 500-0103 | File Document | |

INDICATIONS FOR USE FORM

| 510(k) number (if known): | K033293 |
|---------------------------|---------------------|
| Device Name: | Microkeratome Blade |

Indications for Use:

The MED-LOGICS ML7090 microkeratome blades are to be used, as replacement
blades for the AMO Amadeus
^TM 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)

| Prescription Use<br>Per 21 CFR 801.109 | <div style="text-align:center;">OR</div> | Over-the-Counter Use |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------|
| <div> <img alt="Checkbox" src="checkbox.png"/> </div> Marsha R. Burke Nicholas <div>(Division Sign-Off)</div> Division of Ophthalmic Ear, Nose and Throat Devises | | (Optional Format 1-2-96) |
| 510(k) Number | | |

For Use By Affiliates Of MED-LOGICS, Inc.

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