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510(k) K242393

Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses by Acuity Polymers, Inc. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
August 13, 2024
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 Acuity Polymers, Inc.

  • K240618 — Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hex (April 3, 2024)
  • K230965 — Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with T (June 16, 2023)
  • K213538 — Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact (December 30, 2021)
  • K203571 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (April 9, 2021)
  • K201194 — Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (September 8, 2020)
  • K180988 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon (June 8, 2018)
  • K170001 — Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens (June 2, 2017)
  • K170007 — Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens (May 31, 2017)
  • K163254 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens (January 18, 2017)
  • K162005 — Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens (December 8, 2016)

Other clearances for product code HQD

  • 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)
  • 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)