W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
FDA premarket approval P990072 · decided 2000-08-22
Approval details
- PMA number
- P990072
- Trade name
- W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Westcon Contact Lens Co., Inc.
- Date received
- 1999-11-16
- Decision date
- 2000-08-22
- Days to decision
- 280 days
- Decision code
- APWD
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Grnad Junction, CO
- Statement
- APPROVAL FOR THE HORIZON 55 EW AND HORIZON 55 EW WESTINT (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND VISIBILITY TINT). THESE DEVICES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVEL FOR CLEANING, RINSING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT AS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES (K043540) | Westcon Contact Lens Co., Inc. | 2005-02-01 |
| HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES (K031774) | Westcon Contact Lens Co., Inc. | 2004-02-20 |
| HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) (K023530) | Westcon Contact Lens Co., Inc. | 2002-11-26 |
| W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) (K992010) | Westcon Contact Lens Co., Inc. | 1999-06-29 |
| HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN (K963837) | Westcon Contact Lens Co., Inc. | 1996-12-20 |
| HORIZON/WESTHIN 55-G (K962121) | Westcon Contact Lens Co., Inc. | 1996-08-26 |
| W-55 (METHAFILON A) CONTACT LENS (K954524) | Westcon Contact Lens Co., Inc. | 1996-03-28 |
| HORIZON 55 BI-CON TORIC (K950818) | Westcon Contact Lens Co., Inc. | 1995-03-21 |