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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: AFLE; Anesthesia; Giselle; Haifa Cosmetics; LensMe; Newlens
Classification Name: LENSES, SOFT CONTACT, DAILY WEAR
Product Code: LPL
Device Class: 2
Regulation Number: 886.5925
Medical Specialty: Ophthalmic
Registered Establishment Name: ICODI CO., LTD.
Registered Establishment Number: 3012187418
Premarket Submission Number: K143431
Owner/Operator: iCodi Co., Ltd.
Owner/Operator Number: 10049825
Establishment Operations: Manufacturer
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