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.

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)

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

This document is a 510(k) Summary of Safety and Effectiveness for a rigid gas permeable contact lens, indicating that the device is substantially equivalent to previously cleared devices. It primarily focuses on the device's technical specifications, intended use, and its equivalence to predicate devices based on material properties and function.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods as this information is not present in the provided text.

Summary

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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:	josephDKL@hanmail.net
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

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

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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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1000

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(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

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100 - 100

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510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.