SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
FDA 510(k) clearance K020642 · decided 2002-05-24
Clearance details
- K-number
- K020642
- Device name
- SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
- Applicant
- Soflex Contact Lens Industries , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-27
- Decision date
- 2002-05-24
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.