Last synced on 18 April 2025 at 11:05 pm

IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133079
510(k) Type
Traditional
Applicant
ALDEN OPTICAL LABS., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2013
Days to Decision
78 days
Submission Type
Summary

IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133079
510(k) Type
Traditional
Applicant
ALDEN OPTICAL LABS., INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/17/2013
Days to Decision
78 days
Submission Type
Summary