| Proprietary Name: |
acme 42 aspheric contact lens; acme 42 toric contact lens; Aquarella; Bella Color Monthly Hydrogel (Polymacon) Contact Lenses; BELLA CONTOUR (Polymacon) Contact Lenses; BELLA DIAMOND (Polymacon) Contact Lenses; BELLA ELITE (Polymacon) Contact Lenses; BELLA GLOW (Polymacon) Contact Lenses; BELLA HIGHLIGHT (Polymacon) Contact Lenses; BELLA NATURAL (Polymacon) Contact Lenses; Bella Party Lens POLYMACON Soft hydrophilic lens for daily wear; BELLA SNOW WHITE (Polymacon) Contact Lenses; Crystal Vision Color; Crystal Vision Halloween; Crystal Vision Season; DW Aspheric-38% contact lens; DYE-Dress Your Eyes (Monthly Color Contact Lenses) (Polymacon); Hapa Kristin Colored Contact Lenses; Hapa Kristin Colored Contacts; Hapa Kristin Colored Lenses; Hapa Kristin Contact Lenses; Hapa Kristin Contacts; Hapa Kristin Lenses; Impressions; Iris; Miz; On Vacation Kristin; Playful Kristin; PolyVue; Soft Haze Kristin; Toric-38% contact lens |
| Classification Name: |
LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code: |
LPL |
| Device Class: |
2 |
| Regulation Number: |
886.5925 |
| Medical Specialty: |
Ophthalmic |
| Registered Establishment Name: |
INTEROJO INC.
|
| Registered Establishment Number: |
3004146030
|
| Premarket Submission Number: |
K221517 |
| Owner/Operator: |
INTEROJO INC. |
| Owner/Operator Number: |
9058386
|
| Establishment Operations: |
Manufacturer
|
