FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL

K021752 · Lucid Korea Co., Ltd. · HQD · Oct 11, 2002 · Ophthalmic

Device Facts

• Record ID: K021752
• Device Name: FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL
• Applicant: Lucid Korea Co., Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical(not heat) disinfecting system only.

Device Story

Rigid gas permeable (RGP) contact lenses made of hexafocon A; hemispherical shell design. Corrects refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic patients. Daily wear only; chemical disinfection required. Lens properties include 1.415 refractive index, 92% light transmittance, and <1% water content. Used by patients under eye care professional guidance to improve visual acuity.

Clinical Evidence

No clinical data provided; substantial equivalence based on material and physical property comparisons.

Technological Characteristics

Material: hexafocon A. Form: Hemispherical shell. Diameter: 8.00-10.00mm. Center thickness: 0.10-0.50mm. Base curve: 6.00-9.00mm. Power: -20.0 to +20.0 diopters. Oxygen permeability: 140 (gas to gas/polarographic methods). Water content: <1%. Hardness (Shore D): 81. Refractive index: 1.415. Surface: Hydrophobic.

Indications for Use

Indicated for daily wear for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. Contraindicated for heat disinfection.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• BOSTON XO(hexafocon A) Rigid Gas Permeable Contact Lens (K000795)
• PVS BASICS (paflufocon E) rigid gas permeable contact lenses (K984436)

Submission Summary (Full Text)

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# OCT 11 2002

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR FP(hexafocon A) RGP Contact Lens Spherical ASP(hexafocon A) RGP Contact Lens Aspherical

### Applicant information

| Date Prepared: | May 20, 2002 |
|-----------------|-------------------------------------------|
| Name: | Lucid Korea Co.,Ltd |
| Address: | #748 Keochon-ri Ponghwa-eup, Ponghwa-kun, |
| | Kyungsangbuk-Province, Korea |
| Contact Person: | Dong Kun Lee Technical Manager |
| E-mail Address: | [e-mail] |
| Phone Number: | 82-54-673-8326 |
| FAX Number: | 82-54-673-8327 |
| | |

### Device Information

| Regulatory Classification: | Class II |
|----------------------------|----------------------------------------------|
| Product Code: | HQD |
| Classification Name: | Rigid gas permeable contact lens |
| Trade Name: | FP(hexafocon A) RGP Contact Lens Spherical |
| | ASP(hexafocon A) RGP Contact Lens Aspherical |

## Equivalent Devices:

The FP(hexafocon A) RGP Contact Lens Spherical, ASP(hexafocon A) RGP Contact Lens Aspherical are substantially equivalent to the currently marketed BOSTON XO(hexafocon A) Rigid Gas Permeable Contact Lens, which was cleared 510(k) Premarket Notification No. K000795 and PVS BASICS (paflufocon E) rigid gas permeable contact lenses, which was cleared 510(k) Premarket Notification No. K984436

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## Device Description

FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical(not heat) disinfecting system only.

The FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are is hemispherical shell of the following dimentions.

| · Diameter: | 8.00 to 10.00mm |
|---------------------|------------------------|
| · Center Thickness: | 0.10 to 0.50mm |
| · Base Curve: | 6.00 to 9.00mm |
| · Power: | -20.0 to +20.0 diopter |

The physical properties of the lens are

- · Specific Gravity 1.27
- · Refractive Index 1.415
- · Light Transmittance 92%
- · Surface Character Hydrophobic
- 490 · Wetting Angle
- · Water Content <1%
- · Hardness(shore D) 81
- 140*(100**) { × 10 + ( cm3 O2 cm ) ( cm2 sec mm Hg ) @ 3 5 ℃ } · Oxygen Permeability
- * gas to gas method
- ** polarographic method(ISO/Fatt)

## Intended Use

FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical(not heat) disinfecting system only.

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# Substantial Equivalence:

The following matrix illustrates that the production method, lens function and material of FP(hexafocon A) RGP Contact Lens Spherical, ASP(hexafocon A) RGP Contact Lens Aspherical are substantially equivalent to the predicated device. In addition, the water content, refractive index, specific gravity, wetting angle and light transmission are as well substantial equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lucid Korea CO., Ltd. c/o Dong Kun Lee 748 Keochon-ri Ponghwa-eup Ponghwa-kun Kyungsangbuk-Province Republic of Korea

Re: K021752

Trade Name: FP (hexafocon A) RGP Contact Lens Spherical and ASP (hexafocon A) RGP Contact Lens Aspherical Regulation Number: 21 CFR 886.5916

Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: August 22, 2002 Received: August 27, 2002

Dear Mr. Lee:

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 - Dong Kun Lee

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

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# Indications Statement

# 510(k) Number (if known):

K021752

# Device Name:

FP(hexafocon A) RGP Contact Lens Spherical ASP(hexafocon A) RGP Contact Lens Aspherical

# Indications for Use:

FP(hexafocon A) and ASP(hexafocon A) RGP Contact Lens are indicated for daily wear for the correction of refractive amptropia (myopia, lyperopia, astigmatism) in aphakic and not- aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) 7 Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the Counter Use: Prescription Use: (Per 21 CFR 801.109) (Optional Format 1-2-96)

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Frick Lee Cohen M.D.

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