W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)— 510(k) K992010
Substantially EquivalentWestcon Contact Lens Co., Inc.
FDA 510(k) clearance K992010 for W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED), Substantially Equivalent on 1999-06-29. Applicant: Westcon Contact Lens Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Westcon Contact Lens Co., Inc.
- 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
- Special
- Location
- Grnad Junction, CO, US
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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 Westcon Contact Lens Co., Inc.
view all- K043540 — HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES
- K031774 — HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
- K023530 — HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
- K963837 — HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN
- K962121 — HORIZON/WESTHIN 55-G
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.