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510(k) K171575

ENFLU 18 (enflufocon A) Daily Wear Contact Lens by Contamac, Ltd. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2017
Date Received
May 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

Other clearances by Contamac, Ltd.

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  • K181566 — Nutrifill (October 22, 2018)
  • K180616 — OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafo (April 25, 2018)
  • K171077 — HEXA100 (hexafocon A) Daily Wear Contact Lenses (August 1, 2017)
  • K161100 — Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (August 10, 2016)
  • K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (July 13, 2016)
  • K150590 — CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFL (July 10, 2015)
  • K081178 — OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LEN (October 9, 2008)
  • K070628 — OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. (May 1, 2007)

Other clearances for product code HQD

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  • K230965 — Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with T (June 16, 2023)
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  • K223394 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, (December 7, 2022)
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