(28 days)
Not Found
No
The summary describes a standard rigid gas permeable contact lens and its clinical performance. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
No
The device is a contact lens used for vision correction, not for treating a disease or condition. While it corrects ametropia, it does not involve treating or curing any medical condition.
No
The device is a contact lens intended for correcting refractive ametropia (vision correction), not for diagnosing conditions.
No
The device description clearly states it is a physical contact lens made of a fluoro silicone acrylate polymer, which is a hardware component.
No, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a contact lens used for correcting vision problems (refractive ametropia) by being placed on the surface of the eye. It does not involve the analysis of specimens taken from the body.
- Lack of IVD-related information: The document does not mention any procedures or analyses that would be characteristic of an IVD, such as analyzing biological samples, detecting biomarkers, or diagnosing diseases based on laboratory tests.
Therefore, based on the provided information, the Oxycon contact lens is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Oxycon rigid gas permeable contact lenses are indicated for daily wear correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic), presbyopic or have corneal astigmatism.
Oxycon (wilofocon A) Rigid Gas Permeable, Spherical, Aspherical, Toric, and Bifocal Contact Lenses are indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and nonaphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
86 HQD
Device Description
The Oxycon (wilofocon A) Rigid Gas Permeable Contact Lens is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, wilofocon A, is a fluoro silicone acrylate polymer which contains D&C Green No. 6 as a color additive. The Oxycon (wilofocon A) Contact Lens is a hemispherical shell of the following dimensions:
LENS PARAMETERS AVAILABLE
- Diameter 6.5 to 11.5 mm
- Center Thickness for Low Minus Lens: 0.05 to 0.30 mm, for Plus Lens: 0.10 to 0.70 mm
- Base Curve 6.50 to 9.00 mm
- Powers -20.00 to +20.00 Diopters
*Aspheric Lens Eccentricity Oblate to Prolate - 1.5 to 1.5
Peripheral Curves 0.1 to 10 mm. Flatter or Steeper than Base Curve - Toric Lens Axis 1 to 180 degrees in 1 degree steps, Cylinder power 0.50 to 4.00 Diopters
The physical/optical properties of the lens are: - Specific Gravity 1.25
- Refractive Index (589 nm at 25°C) 1.44
- Light Transmittance Clear (370-760 nm) 93%, Tinted (D&C Green No. 6) (380-780 nm) 87%
- Surface Character Hydrophobic
- Wetting Angle (CLMA Method) 23.0 ± 2
- Water Content (Gravimetric method at 22°C)
§ 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
Submitted by:
Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street NW (Suite 700) Washington, DC 20036
On behalf of Con-Cise Contact Lens Co., Inc. 510(k) Submission: Oxycon™ RGP Contact Lens
| Device Classification: | Rigid Gas Permeable Contact Lens (21 CFR 886.5916) |
|---|---|
| Predicate Device: | Oxycon Rigid Gas Permeable Contact Lens (K974636) |
| * * |
-
|
| NAME AND USE OF DEVICE | |
| Device Generic Name: | wilofocon A |
| Device Trade Name: | Oxycon rigid gas permeable contact lens |
| Indications: | Oxycon rigid gas permeable contact lenses
are indicated for daily wear correction of
visual acuity in aphakic and non-aphakic
persons with non-diseased eyes who are
nearsighted (myopic), farsighted (hyperopic),
presbyopic or have corneal astigmatism. |
| Airperm Ranges: | Chord diameter 6.5 to 11.5 mm
Center thickness 0.05 to 0.70 mm
Base Curve 6.50 to 9.00 mm
Powers -20.00 to +20.00 diopters |
| Cleaning and Disinfection: | The Oxycon rigid gas permeable contact lens
must be disinfected using only a chemical
(not heat) disinfection system as
recommended. |
1
DEVICE CHARACTERISTICS
The Oxycon (wilofocon A) Rigid Gas Permeable Contact Lens is available as a spherical, aspherical, and astigmatic (toric) lens. The lens material, wilofocon A, is a fluoro silicone acrylate polymer which contains D&C Green No. 6 as a color additive. The Oxycon (wilofocon A) Contact Lens is a hemispherical shell of the following dimensions:
LENS PARAMETERS AVAILABLE
| * Diameter | 6.5 to 11.5 mm |
|---|---|
| * Center Thickness | |
| for Low Minus Lens: | |
| for Plus Lens: | 0.05 to 0.30 mm |
| 0.10 to 0.70 mm | |
| * Base Curve | 6.50 to 9.00 mm |
| * Powers | -20.00 to +20.00 Diopters |
| *Aspheric Lens Eccentricity | |
| Oblate to Prolate | - 1.5 to 1.5 |
| Peripheral Curves | 0.1 to 10 mm. Flatter or Steeper than Base Curve |
| * Toric Lens | |
| Axis | |
| Cylinder power | 1 to 180 degrees in 1 degree steps |
| 0.50 to 4.00 Diopters | |
| The physical/optical properties of the lens are: | |
| * Specific Gravity | 1.25 |
| * Refractive Index (589 nm at 25°C) | 1.44 |
| * Light Transmittance | |
| Clear (370-760 nm) | |
| Tinted (D&C Green No. 6) (380-780 nm) | 93% |
| 87% | |
| * Surface Character | Hydrophobic |
| * Wetting Angle (CLMA Method) | 23.0 ± 2 |
| * Water Content (Gravimetric method at 22°C) |