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FDA 510(k)

NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY

K-Number: K032309 · 2003-12-04

ApplicantNovelens, Inc.
Decision Date2003-12-04
Product CodeLRX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Novelens, Inc.. It received FDA 510(k) clearance on 2003-12-04 under 510(k) number K032309. 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 NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY?

NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY is a medical device that received FDA 510(k) clearance on 2003-12-04. The listed applicant is Novelens, Inc.. The 510(k) number is K032309.

When did NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY receive FDA 510(k) clearance?

NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY received FDA 510(k) clearance on 2003-12-04, under 510(k) number K032309.

Who is the listed applicant for NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY?

The FDA 510(k) record lists Novelens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY?

The FDA product code for NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY is LRX.

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Related Devices (Code: LRX)

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.

K252175LANDR Contact LENS CaseFourth Axis, LLCK250495MINI 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

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

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