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510(k) K180172

FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG by Paragon Vision Sciences — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2018
Date Received
January 22, 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 Paragon Vision Sciences

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  • 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)
  • K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK (February 28, 2001)
  • 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 HQD

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  • 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)