Cleared Traditional

HDS HI 1.54

K082799 · Paragon Vision Sciences · Ophthalmic
Jan 2009
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K082799 is an FDA 510(k) clearance for the HDS HI 1.54, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Paragon Vision Sciences (Mesa, US). The FDA issued a Cleared decision on January 27, 2009, 126 days after receiving the submission on September 23, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K082799 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2008
Decision Date January 27, 2009
Days to Decision 126 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 Paragon Vision Sciences

View all
FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
K180172 · HQD · Mar 2018
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
K120996 · HQD · Jun 2012
FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
K070637 · HQD · May 2007
FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES
K052983 · HQD · Feb 2006
PVS BASIC 2; EPIC 2
K013310 · HQD · Apr 2002