FDA 510(k)

PARAGON LENS CARE

K-Number: K974635 · 1998-02-04

Decision Date1998-02-04

Product CodeLRX

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PARAGON LENS CARE is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Vision Sciences. It received FDA 510(k) clearance on 1998-02-04 under 510(k) number K974635. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARAGON LENS CARE?

PARAGON LENS CARE is a medical device that received FDA 510(k) clearance on 1998-02-04. The listed applicant is Paragon Vision Sciences. The 510(k) number is K974635.

When did PARAGON LENS CARE receive FDA 510(k) clearance?

PARAGON LENS CARE received FDA 510(k) clearance on 1998-02-04, under 510(k) number K974635.

Who is the listed applicant for PARAGON LENS CARE?

The FDA 510(k) record lists Paragon Vision Sciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAGON LENS CARE?

The FDA product code for PARAGON LENS CARE is LRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Paragon Vision Sciences as applicant

K180172FluoroPerm 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 K120996FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN K082799HDS HI 1.54 K070637FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES K052983FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES K013310PVS BASIC 2; EPIC 2

View all 15 devices →

Related Devices (Code: LRX)

K252175LANDR Contact LENS CaseFourth Axis, LLC K250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)Shanghai Care US Medical Product Co., Ltd.K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc.K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.