KONTUR 55 EW
FDA premarket approval P850078 · decided 1986-01-31
Approval details
- PMA number
- P850078
- Trade name
- KONTUR 55 EW
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Kontur Kontact Lens Co., Inc.
- Date received
- 1985-10-30
- Decision date
- 1986-01-31
- Days to decision
- 93 days
- Decision code
- APWD
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Hercules, CA
- Statement
- APPROVAL FOR THE SPHERICAL AND TORIC CONFIGURATIONS OF THE KONTUR SOFTMETHAFILCON A HY4ROPHILIC CONTACT LENS THE SPHERICAL LENS IS INDICATED FORDAILY WEAR FOR THE CORRECTION OF VISUAL ACUITY IN APHAKIC AND NOT APHAKICPERSONS WITH NONDISEASED EYES THAT ARE MYOPIC OR HYPEROP1C THE LENS MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 1 50 DIOPTERS D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY THE LENS RANGES 1N POWERS FROM 20 00 D TO 20 00 D THE TORIC LENS IS INDICATED FOR DAILY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| KONTUR 55 SOFT LENS (K001908) | Kontur Kontact Lens Co., Inc. | 2000-08-18 |