Last synced on 25 January 2026 at 3:41 am

ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110261
510(k) Type
Traditional
Applicant
Soflex Limited
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2011
Days to Decision
181 days
Submission Type
Statement

ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110261
510(k) Type
Traditional
Applicant
Soflex Limited
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/28/2011
Days to Decision
181 days
Submission Type
Statement