Cleared Traditional

BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

K022128 · Bausch & Lomb, Incorporated · Ophthalmic
Aug 2002
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K022128 is an FDA 510(k) clearance for the BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on August 22, 2002, 52 days after receiving the submission on July 1, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K022128 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2002
Decision Date August 22, 2002
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

Similar Devices — HQD Lens, Contact (other Material) - Daily

All 116
Acuity 181? (tisilfocon A) and Acuity 181? (tisilfocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lenses
K242393 · Acuity Polymers, Inc. · Nov 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
K241398 · Tianjin Mastervision Technology Co., Ltd. · Oct 2024
BostonSight? Specialty Lenses
K241571 · Boston Foundation For Sight, Inc. D/B/A Bostonsight · Aug 2024
Acuity 200? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100? (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200? with Tangible? Hydra-PEG? (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100? with Tangible? Hydra-PEG? (hexafocon A) Rigid Gas Permeable Contact Lens
K240618 · Acuity Polymers, Inc. · Apr 2024
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)
K233325 · Visionary Optics, LLC · Feb 2024
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
K230910 · Acculens, Inc. · Jun 2023

More from Bausch & Lomb, Incorporated

View all
EyeGility? Inserter for Preloaded enVista IOLs
K242389 · MSS · Oct 2024
Samfilcon B Custom Contact Lens
K230954 · LPL · Nov 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K220613 · LPL · Mar 2023
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · LPN · Dec 2022
Independent Corneal Viewing Chamber (IVC-21)
K211786 · LYX · Dec 2021