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510(k) K010109

FLUOROPERM 151-OK, PARAGON HDS 100-OK by Paragon Vision Sciences — Product Code MUW

K010109 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "FLUOROPERM 151-OK, PARAGON HDS 100-OK". The FDA issued a decision of SESU on February 28, 2001. The device falls under product code MUW (Lens, Contact (Orthokeratology)), a Class II device regulated under 21 CFR 886.5916. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
February 28, 2001
Date Received
January 12, 2001
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 Paragon Vision Sciences

  • K221768 — Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses (May 5, 2023)
  • K180172 — FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hyd (March 16, 2018)
  • K120996 — FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM (June 28, 2012)
  • K082799 — HDS HI 1.54 (January 27, 2009)
  • K070637 — FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEA (May 1, 2007)
  • K052983 — FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERME (February 10, 2006)
  • K013310 — PVS BASIC 2; EPIC 2 (April 25, 2002)
  • K002845 — PAFLUFOCON C AND E DAILY CONTACT LENS (December 8, 2000)
  • K993586 — SPORTSIGHT GP (May 22, 2000)
  • K000224 — FLUROPERM 60-OK, PARAGON HDS-OK (April 17, 2000)

Other clearances for product code MUW

  • K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (January 9, 2019)
  • K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (July 13, 2016)
  • 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