CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)— 510(k) K023989
Substantially EquivalentContamac, Ltd.
FDA 510(k) clearance K023989 for CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT), Substantially Equivalent on 2003-02-26. Applicant: Contamac, Ltd.. Device class: 2.
Clearance details
- Applicant
- Contamac, Ltd.
- 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
- Grand Junction, CO, US
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More clearances from Contamac, Ltd.
view all- K212631 — Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
- K182304 — Hyper GP (tisilfocon A) Daily Wear Contact Lens
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- K180616 — OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
- K171575 — ENFLU 18 (enflufocon A) Daily Wear 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.