OxySoft (olifilcon C) silicone hydrogel soft contact lens— 510(k) K191397
Substantially EquivalentVisco Vision, Inc.
FDA 510(k) clearance K191397 for OxySoft (olifilcon C) silicone hydrogel soft contact lens, Substantially Equivalent on 2019-10-02. Applicant: Visco Vision, Inc.. Device class: 2.
Clearance details
- Applicant
- Visco Vision, Inc.
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taoyuan City, TW
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- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
More clearances from Visco Vision, Inc.
view all- K200618 — HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens
- K201080 — Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens
- K183670 — Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens +1 more
- K181349 — Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens +1 more
- K180322 — Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.