Home / 510(k) Clearances / K120996

510(k) K120996

FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN by Paragon Vision Sciences — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2012
Date Received
April 2, 2012
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

  • 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)
  • 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

  • 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)