Home / 510(k) Clearances / K183167

510(k) K183167

Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens by Bausch & Lomb, Incorporated — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2019
Date Received
November 15, 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 Bausch & Lomb, Incorporated

  • K242389 — EyeGility™ Inserter for Preloaded enVista IOLs (October 10, 2024)
  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kal (March 8, 2023)
  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • K202932 — ABT12 multi-purpose solution (May 28, 2021)
  • K210975 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (May 24, 2021)
  • K200416 — Boston One Step Liquid Enzymatic Cleaner (September 23, 2020)
  • K182249 — Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (November 30, 2018)
  • K181627 — Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step (August 10, 2018)
  • K180319 — Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning (March 27, 2018)

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)