Company ยท US
Vistakon
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2004. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2004 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS Vistakon | LPL |
| Feb 4, 2004 | K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER Vistakon | LPL |
| Feb 26, 2002 | K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC Vistakon | LPL |
| Apr 12, 2001 | K010507 | VISTAKON (METHAFILCON A) CONTACT LENSES Vistakon | LPL |
| Mar 16, 2001 | K010218 | VISTAKON (HEFILCON C) CONTACT LENSES Vistakon | LPL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2010 | Vistakon Primary (inner) Package Label: ACUVUE OASYS BRAND CONTACT LENSES for ASTIGMATISM with HYDRACLEAR Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, STERILE. Lot B006WBS1 -9.00D -1.25 C Terminated |
LPM | None listed |
| Sep 18, 2009 | Vistakon Acuvue Advance for Astigmatism Diagnostic Product.
Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07.
Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis E Terminated |
LPL | None listed |