Company
Alden Optical
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2018 | Alden Optical Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows:
Zen RC TPC (Toric Peripheral Curve)
Zen RC FT (Front Toric Optics)
Catalog Number: AOZNT
Zenlen Terminated |
HQD | K033594 K071043 +1 |
| Jul 3, 2018 | Alden Optical Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows:
Zenlens FT(Front Toric);
Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault);
Zenlens TPC-(T Terminated |
HQD | K033594 K071043 +1 |
| Nov 3, 2017 | Alden Optical ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54
Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic Terminated |
LPL | K052703 |
| Nov 3, 2017 | Alden Optical Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59
Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic person Terminated |
LPL | K042242 |
| Nov 3, 2017 | Alden Optical Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55
Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic Terminated |
LPL | K042242 |
| Nov 3, 2017 | Alden Optical Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54
Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic person Terminated |
LPL | K091327 |
| Nov 3, 2017 | Alden Optical Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49
Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic person Terminated |
LPL | K981252 |
| Nov 3, 2017 | Alden Optical Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic pers Terminated |
LPL | K042242 |
| Nov 3, 2017 | Alden Optical Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic pers Terminated |
LPL | K091327 |
| Nov 3, 2017 | Alden Optical Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic pe Terminated |
LPL | K981252 |
| Nov 3, 2017 | Alden Optical Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphaki Terminated |
LPL | K973967 |
| Nov 3, 2017 | Alden Optical NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54
Product Usage:
The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of r Terminated |
LPL | K102557 |
| Nov 3, 2017 | Alden Optical NovaKone Daily Wear Soft contact; Catalog Number: AONKS54
Product Usage:
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of ref Terminated |
LPL | K102557 |