CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS

K992950 · Prosthetic Soft Lens Corp. · LPL · Nov 18, 1999 · Ophthalmic

Device Facts

• Record ID: K992950
• Device Name: CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
• Applicant: Prosthetic Soft Lens Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eve. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.

Device Story

Prosthetic (hefilcon A) soft contact lens; daily wear; used for cosmetic masking of ocular abnormalities or refractive correction. Lens matrix incorporates titanium dioxide as white opaquing agent; custom-printed or painted with reactive dyes by artists per practitioner specifications. Lens may be opaque for non-sighted eyes or clear-centered for sighted eyes. Prescribed by eye care practitioners; patient wears lens to improve appearance or manage conditions like diplopia or photophobia. Chemical disinfection system used for maintenance. Permanent colorants/opaquing agents prevent leaching.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Soft contact lens composed of hefilcon A polymer. Incorporates titanium dioxide as white opaquing agent and reactive dyes for iris/pattern printing. Daily wear modality. Chemical disinfection compatible. Dimensions and form factor are standard for soft contact lenses.

Indications for Use

Indicated for daily wear in sighted or non-sighted persons requiring cosmetic management of corneal, iris, scleral, or lens abnormalities, or for cosmetic enhancement. Also indicated for refractive correction (myopia, hyperopia, astigmatism) in aphakic or non-aphakic persons, and occlusive therapy for diplopia, amblyopia, or extreme photophobia.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• Prosthetic (polymacon) Hydrophilic Contact Lens (K984259)
• Classic Prosthetic (polymacon) (K983053)
• Oxylens tinted Prosthetic (hioxifilcon B) (K983278)

Submission Summary (Full Text)

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

Nov 1 8 1999

# 510(k) #K992950

## 510(k) SUMMARY

#### Applicant Information:

Date Prepared: August 26, 1999

Submitted by: Prosthetic Soft Lens Company 2890 South Tejon Street Englewood, CO 80110

Contact Person: Phone: Fax: Email:

William Hoffman 303-789-0933 303-789-4506 [e-mail]

#### Device Information:

| Trade Name: | Prosthetic (hefilcon A) Soft Lens |
|----------------------|-----------------------------------|
| Classification Name: | Lens, Soft Contact, Daily Wear |
| Class and Number: | Class II, LPL |

Substantially Equivalent to:

- (1) Prosthetic (polymacon) Hydrophilic Contact Lens, K984259
- (2) Classic Prosthetic (polymacon), K983053

(3) Oxylens tinted Prosthetic (hioxifilcon B), K983278

Device Description:

The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The approved pigment, titanium dioxide, is incorporated into the lens matrix as the white opaquing agent. Lenses are printed or painted by skilled artists to a eye care practitioners specifications with approved reactive dyes. The opaquing agent and colorants are permanent and are not leached from a lens.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Mr. William Hoffman President Prosthetic Soft Lens Corporation 2890 South Tejon Street Englewood, CO 80110

Re: K992950 Trade Name: Prosthetic (hefilcon A) Soft Contact Lens Product Code: 86 LPL Dated: September 8, 1999 Received: September 14, 1999

Dear Mr. Hoffman:

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 (QS) 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 .

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

Page 2 - Mr. William Hoffman

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,

ARalph Rosenthal

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

Enclosure

{3}------------------------------------------------

Page 1 of 1

### 510(k) NUMBER (IF KNOWN): K992950

DEVICE NAME: Prosthetic (hefilcon A) Soft Contact Lens

INDICATIONS FOR USE:

The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eve. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brown

510(k) Number ..

ion Sign-Off)
ion of Ophthalmic Devices
) Number: K992950

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)