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FDA 510(k)

ROSE K LENS

K-Number: K945955 · 1995-02-07

ApplicantRose K International , Ltd.
Decision Date1995-02-07
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ROSE K LENS is the device name listed in this FDA 510(k) record. The listed applicant is Rose K International , Ltd.. It received FDA 510(k) clearance on 1995-02-07 under 510(k) number K945955. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSE K LENS?

ROSE K LENS is a medical device that received FDA 510(k) clearance on 1995-02-07. The listed applicant is Rose K International , Ltd.. The 510(k) number is K945955.

When did ROSE K LENS receive FDA 510(k) clearance?

ROSE K LENS received FDA 510(k) clearance on 1995-02-07, under 510(k) number K945955.

Who is the listed applicant for ROSE K LENS?

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

What is the FDA product code for ROSE K LENS?

The FDA product code for ROSE K LENS is HQD.

Other records listing Rose K International , 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.

K013646ROSE K POST GRAFT LENS

Related Devices (Code: HQD)

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.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 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 LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

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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