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510(k) K180616

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens by Contamac, Ltd. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2018
Date Received
March 8, 2018
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.

  • K212631 — Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (March 17, 2022)
  • K182304 — Hyper GP (tisilfocon A) Daily Wear Contact Lens (November 23, 2018)
  • K181566 — Nutrifill (October 22, 2018)
  • K171575 — ENFLU 18 (enflufocon A) Daily Wear Contact Lens (October 24, 2017)
  • 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

  • K242393 — Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-P (November 1, 2024)
  • K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (October 22, 2024)
  • K241571 — BostonSight® Specialty Lenses (August 14, 2024)
  • K240618 — Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hex (April 3, 2024)
  • K233325 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, (February 21, 2024)
  • K230965 — Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with T (June 16, 2023)
  • K230910 — NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisil (June 16, 2023)
  • K221768 — Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (May 5, 2023)
  • K223394 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, (December 7, 2022)
  • K212631 — Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (March 17, 2022)