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FDA 510(k)

BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY

K-Number: K003932 · 2001-02-16

ApplicantPolymer Technology
Decision Date2001-02-16
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology. It received FDA 510(k) clearance on 2001-02-16 under 510(k) number K003932. 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 BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY?

BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY is a medical device that received FDA 510(k) clearance on 2001-02-16. The listed applicant is Polymer Technology. The 510(k) number is K003932.

When did BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY receive FDA 510(k) clearance?

BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY received FDA 510(k) clearance on 2001-02-16, under 510(k) number K003932.

Who is the listed applicant for BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY?

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

What is the FDA product code for BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY?

The FDA product code for BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY is HQD.

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.

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Other records listing Polymer Technology 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.

K003933BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGYK002025RIGID GAS PERMEABLE CONTACT LENSK001960RIGID GAS PERMEABLE CONTACT LENSK000795RIGID GAS PERMEABLE CONTACT 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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