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FDA 510(k)

SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE

K-Number: K033656 · 2004-02-02

ApplicantSauflon Pharmaceuticals, Ltd.
Decision Date2004-02-02
Product CodeLRX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE is the device name listed in this FDA 510(k) record. The listed applicant is Sauflon Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2004-02-02 under 510(k) number K033656. 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 SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE?

SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE is a medical device that received FDA 510(k) clearance on 2004-02-02. The listed applicant is Sauflon Pharmaceuticals, Ltd.. The 510(k) number is K033656.

When did SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE receive FDA 510(k) clearance?

SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE received FDA 510(k) clearance on 2004-02-02, under 510(k) number K033656.

Who is the listed applicant for SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE?

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

What is the FDA product code for SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE?

The FDA product code for SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE is LRX.

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Other records listing Sauflon Pharmaceuticals, Ltd. as applicant

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.

K130342SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERK130331SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERK130734SAUFLON MULTIPURPOSE SOLUTIONK052832SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSESK052809SAUFLON FLAT COLOURED LENS CASEK030278SAUFLON MULTIPURPOSE SOLUTION - NO RUB

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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

View on FDA Database →

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

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