(57 days)
Gold Medalist Toric lenses
Not Found
No
The 510(k) summary describes a standard soft contact lens and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development. The performance studies are clinical trials evaluating the physical properties and clinical performance of the lens itself.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which is not considered a therapeutic treatment, but rather a correction of vision. It is explicitly stated that the device is for "non-aphakic persons with non-diseased eyes."
No
The device is a contact lens indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which is a treatment for a condition rather than a diagnostic tool used to identify or measure a disease or condition.
No
The device description clearly describes a physical contact lens made of a specific material with defined dimensions and properties. It is a tangible hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Igel® 56 UV contact lens is a device that is placed on the human eye to correct vision. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it is for "correction of refractive ametropia" and is worn "for daily wear." This is a therapeutic/corrective function, not a diagnostic one.
The provided information describes a medical device used for vision correction, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Igel®56 UV (hefilcon C) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism, for the spherical lens up to 1.50 diopters that does not interfere with visual acuity, and for the toric lens up to 7.00 diopters) in not-aphakic persons with non-diseased eyes. The lens may be disinfected using chemical disinfecting systems only.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power: -0.50D to -8.00D (in 0.25D steps); -8.50D to -12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps). The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
The Igel® 56 UV (hefilcon C) Soft (hydrophilic) Toric Contact Lens has the following characteristics: 14.6mm Chord diameter: 0.15mm Center thickness: 8 - 4 5mm Optic Zone: 8.70mm Base Curve: Plano to -8.00 D (in 0.25 D steps) Sphere: Plano to +6.00 D (in 0.25 D steps) up to 7.00 D Cylinder: 80, 90, 100, 160, 170, 180, 10 & 20 Axis : Dynamic Stabilizing Stabilizing Mechanism: Sectors.
The physical properties of the lens (sphere or toric) are as follows: Specific Gravity: 1.16 Refractive index: 1.41 (hydrated) Light transmission: 94.5% (clear) 90.3% (blue handling tint) UV transmittance:
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
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.(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
984523 510(k) SUMMARY FOR FREEDOM OF INFORMATION, K984523 IGEL® 56 UV (hefilcon C) SOPT (hydrophilic) CONTACT LENS FOR DAILY WEAR NOTE: This summary is identical to that provided for K974837, except for the name change, the inclusion of the UV absorbing compound in the material description, and the inclusion of the UV transmittance in the physical properties. Labeling changes include the name change and the inclusion of the appropriate UV transmittance graphs and warnings. Igel Vision Care PTE, Ltd l. Submitted by: 139 Joo Seng Road, #06-01 ATD Centre Singapore 368362 John M. Szabocsik, Ph.D. Contact : Official agent Szabocsik and Associates 203 N. Wabash, Ste 1200 Chicago, IL 60601 (312) 553-0828 February 9, 1999 2. Date prepared: 3. Device: Igel® 56 UV (hefilcon C) Soft (hydrophilic) Common Name Contact Lens Igel® 56 UV (hefilcon C) Soft (hydrophilic) Trade Name Contact Lens Class II (Performance Standards) 4. Classification 21 CFR 886.5925 Soft (hydrophilic) contact lens This product is substantially 5. Substantial equivalent to other currently marketed equivalence hefilcon lenses, such as Gold Medalist Toric lenses 6. Device The Igel® 56 UV (hefilcon C) soft (hydrophilic) contact lens is a description hemispherical, flexible transparent shell of the following dimensions: Chord diameter: 14.2mm Center thickness: 0.09mm (at-3.00 D) Optic Zone: variable optic zone with power Base Curve: 8.60mm Power : -0.50D to -8.00D (in 0.25D steps); -8.50D to
-12.00D (in 0.50D steps); +0.50D to +6.00D (in 0.25D steps)
1
The lens material (hefilcon C) is a copolymer of 2 hydroxethylmethacrylate and N-Vinyl pyrrolidone, and contains a UV absorbing compound. The blue tinted lens also contains D&C Green #6. When fully hydrated, the lens is 56% water by weight.
- The Igel® 56 UV (hefilcon C) Soft 7. Intended use (hydrophilic) Contact Lens for Daily Wear is available as a spherical lens for the correction of near-sightedness (myopia) and farsightedness (hyperopia). A toric version of the same lens is able to correct for astiqmatism from 0.50D to 7.00D.
-
- Comparison to predicate devices: see following table
SUBSTANTIAL EQUIVALENCE
| Material | Igel® 56 UV
hefilcon C | Gold Medalist™ Toric
hefilcon C |
|-------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Description | random copolymer of
2-hydroxyethyl
methacrylate and N-
vinyl-2-pyrrolidone | random copolymer of
2-hydroxyethyl
methacrylate and N-
vinyl-pyrrolidone |
| Water Content | 56% in buffered
saline | 57% in normal saline |
| Specific
Gravity | 1.16 | 1.1 |
| Refractive
Index | 1.41 (hydrated) | 1.41 |
| Light
Transmittance
(visible) | 94.5% (clear)
90.3% (blue handling
tint) | at least 90% |
| UV
Transmittance |