FDA Browser

Last synced on 18 April 2025 at 11:05 pm

subpart-f—therapeutic-devices/

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K004000
510(k) Type: Traditional
Applicant: OCU-EASE OPTICAL PRODUCTS, INC.
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 2/21/2001
Days to Decision: 57 days
Submission Type: Statement

FDA Browser

subpart-f—therapeutic-devices/

OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K004000
510(k) Type: Traditional
Applicant: OCU-EASE OPTICAL PRODUCTS, INC.
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 2/21/2001
Days to Decision: 57 days
Submission Type: Statement