I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2— 510(k) K033136
Substantially EquivalentInnova Vision, Inc.
FDA 510(k) clearance K033136 for I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2, Substantially Equivalent on 2004-03-05. 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
- Flagstaff, AZ, US
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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
- K222954 — Innova Vision Hydrogel (Etafilcon A) 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
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.