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510(k) K160859

OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) by Contamac, Ltd. — Product Code MUW

K160859 is an FDA 510(k) premarket notification submitted by Contamac, Ltd. for the device "OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)". The FDA issued a decision of Substantially Equivalent on July 13, 2016. The device falls under product code MUW (Lens, Contact (Orthokeratology)), a Class II device regulated under 21 CFR 886.5916. Contamac, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2016
Date Received
March 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Orthokeratology)
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)
  • K180616 — OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafo (April 25, 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)
  • 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 MUW

  • K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (January 9, 2019)
  • K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK (February 28, 2001)
  • K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K000224 — FLUROPERM 60-OK, PARAGON HDS-OK (April 17, 2000)
  • K973697 — AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTH (April 8, 1998)

FDA data resources