CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES— 510(k) K073459
Substantially EquivalentCiba Vision Corporation
FDA 510(k) clearance K073459 for CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES, Substantially Equivalent on 2008-02-28. Applicant: Ciba Vision Corporation. Device class: 2.
Clearance details
- Applicant
- Ciba Vision Corporation
- Product code
- 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
- Duluth, GA, US
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- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
More clearances from Ciba Vision Corporation
view all- K133176 — AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
- K123994 — DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
- K113168 — DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
- K083216 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
- K072777 — CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
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.