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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: AMARA CONTACT LENS; Amara Lens; Another Me Kristin; Attention-Plz Kristin; Barris Land; Day n' Night Kristin; Debut Kristin; Dimple Color; Dimple Color Colour Lenses; Dimple Color Contact Lenses; Dimplecolor 1-day colour lenses; Doll Nikita; Eyereve Colors 1-day; Grrrr Kristin; Hapa Kristin Colored Contact Lenses; Hapa Kristin Colored Contacts; Hapa Kristin Colored Lenses; Hapa Kristin Contact Lenses; Hapa Kristin Contacts; Hapa Kristin Lenses ; Lovesick Kristin; Lucid Kristin; One of a Kind Kristin; Ooptimus; Sophisticated Kristin; SWATI coloured lenses; SWATI lenses; Sweet Tooth Kristin; Trick or Treat Kristin
Classification Name: LENSES, SOFT CONTACT, DAILY WEAR
Product Code: LPL
Device Class: 2
Regulation Number: 886.5925
Medical Specialty: Ophthalmic
Registered Establishment Name: VISION SCIENCE CO., LTD.
Registered Establishment Number: 3006946962
Premarket Submission Number: K161124
Owner/Operator: VISION SCIENCE CO., LTD.
Owner/Operator Number: 10046391
Establishment Operations: Manufacturer
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