(136 days)
No
The summary describes a standard rigid gas permeable contact lens with physical dimensions and properties, and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which are vision corrections, not treatments for a disease or condition.
No
This device is described as a "RGP Contact Lens" used for "correction of refractive ametropia (myopia, hyperopia and astigmatism)". It is a corrective device, not one used for diagnosis.
No
The device description clearly describes a physical contact lens with specific dimensions and material properties, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a contact lens intended for the correction of refractive ametropia (vision problems like myopia, hyperopia, and astigmatism) by being placed directly on the eye.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens from the patient. Its function is purely mechanical/optical correction of vision.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HQD
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
§ 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.
0
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
1
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