CONTACT LASER & DIAGNOSTIC LENSES

K023221 · Volk Optical, Inc. · HJK · Oct 11, 2002 · Ophthalmic

Device Facts

• Record ID: K023221
• Device Name: CONTACT LASER & DIAGNOSTIC LENSES
• Applicant: Volk Optical, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.

Device Story

Contact Laser & Diagnostic Lenses are specialized ophthalmic lenses used by eye care professionals during clinical examinations and therapeutic procedures. The lenses are placed on the patient's eye to facilitate visualization of the fundus or to deliver laser therapy for intraocular abnormalities. These devices function as optical aids, allowing the clinician to view internal eye structures or focus laser energy precisely. They are used in clinical settings by ophthalmologists or optometrists. The output is a magnified or focused view of the ocular anatomy, enabling diagnosis and targeted treatment of eye conditions. The device benefits patients by providing non-invasive access to the posterior segment of the eye for diagnostic and therapeutic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polymethylmethacrylate (PMMA) diagnostic contact lens. Class II device (21 CFR 886.1385). Product code HJK.

Indications for Use

Indicated for patients requiring eye fundus examination or therapy for intraocular abnormalities. Prescription use only.

Regulatory Classification

Identification

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

Submission Summary (Full Text)

{0}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volk Ontical, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road, Suite 30 Rockville, MD 20850

Re: K023221

Trade/Device Name: Contact Laser & Diagnostic Lenses Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: September 25, 2002 Received: September 27, 2002

Dear Dr. Lippman:

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.

{1}------------------------------------------------

## Page 2 - Richard E. Lippman, O.D., F.A.A.O.

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/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

{2}------------------------------------------------

# Indications Statement

K023221 510(k) Number (if known)

Device Name: Contact Laser & Diagnostic Lenses

## Indications for Use:

The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.

## Additional Claims:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Presription Use

OR

Over -The-Counter Use ________________________________________________________________________________________________________________________________________________________

(Oprtional Format 1-2-96)

Daniel W. C. Brown, Ph.D.
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number ________________________________________________________________________________________________________________________________________________________________