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510(k) K233325

Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) by Visionary Optics, LLC — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2024
Date Received
September 29, 2023
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 Visionary Optics, LLC

  • K223394 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, (December 7, 2022)
  • K171950 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, (August 16, 2017)

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)
  • K230910 — NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisil (June 16, 2023)
  • K230965 — Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with T (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)
  • K213880 — Custom Stable Rigid Gas Permeable Scleral Contact Lens (January 7, 2022)