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510(k) K183200

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses by C&E GP Specialist, Inc. — Product Code MUW

K183200 is an FDA 510(k) premarket notification submitted by C&E GP Specialist, Inc. for the device "iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses". The FDA issued a decision of Substantially Equivalent on January 9, 2019. The device falls under product code MUW (Lens, Contact (Orthokeratology)), a Class II device regulated under 21 CFR 886.5916.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2019
Date Received
November 19, 2018
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 for product code MUW

  • K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (July 13, 2016)
  • 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