HORIZON 55 BI-CON TORIC
FDA 510(k) clearance K950818 · decided 1995-03-21
Clearance details
- K-number
- K950818
- Device name
- HORIZON 55 BI-CON TORIC
- Applicant
- Westcon Contact Lens Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-23
- Decision date
- 1995-03-21
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grnad Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES (P990072) | Westcon Contact Lens Co., Inc. | 2000-08-22 |
| TECHNICON-38 POLYMACON HYDROPHILIC LENS (P900065/S003) | Westcon Contact Lens Co., Inc. | 1993-02-11 |
| FLEXLENS (HEFILCON A) SOFT CONTACT LENSES (P900058/S001) | Westcon Contact Lens Co., Inc. | 1991-08-29 |
| TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES (P900065/S001) | Westcon Contact Lens Co., Inc. | 1991-08-29 |