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FDA 510(k)

BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY

K-Number: K003933 · 2001-02-16

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

Device Summary

BOSTON EQUALENS II (OPRIFOCON A) 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 K003933. The device is classified under product code MUW. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY?

BOSTON EQUALENS II (OPRIFOCON A) 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 K003933.

When did BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY receive FDA 510(k) clearance?

BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY received FDA 510(k) clearance on 2001-02-16, under 510(k) number K003933.

Who is the listed applicant for BOSTON EQUALENS II (OPRIFOCON A) 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 EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY?

The FDA product code for BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY is MUW.

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.

K003932BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGYK002025RIGID GAS PERMEABLE CONTACT LENSK001960RIGID GAS PERMEABLE CONTACT LENSK000795RIGID GAS PERMEABLE CONTACT LENS

Related Devices (Code: MUW)

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.

K183200iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact LensesC&E GP Specialist, Inc.K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd.K010109FLUOROPERM 151-OK, PARAGON HDS 100-OKParagon Vision SciencesK000224FLUROPERM 60-OK, PARAGON HDS-OKParagon Vision SciencesK973697AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGYAirperm, Inc.

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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