Cleared Traditional

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

K241398 · Tianjin Mastervision Technology Co., Ltd. · Ophthalmic
Oct 2024
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K241398 is an FDA 510(k) clearance for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Tianjin Mastervision Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on October 22, 2024, 159 days after receiving the submission on May 16, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K241398 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2024
Decision Date October 22, 2024
Days to Decision 159 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
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
Acuity 100? (hexafocon A) with Tangible? Hydra-PEG?, TYRO?-97 (hofocon A) with Tangible? Hydra-PEG? Rigid Gas Permeable Contact Lens
K230965 · Acuity Polymers, Inc. · Jun 2023