Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens— 510(k) K222954
Substantially EquivalentInnova Vision, Inc.
FDA 510(k) clearance K222954 for Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens, Substantially Equivalent on 2023-03-13. Applicant: Innova Vision, Inc.. Device class: 2.
Clearance details
- Applicant
- Innova 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
- Hsinchu, TW
Recent devices under product code LPL
view all- K260311 — Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- K253875 — OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens +2 more
- K262941 — Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
More clearances from Innova Vision, Inc.
view all- K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
- K232139 — Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
- K213119 — Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
- K112373 — CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
- K083288 — DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
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.