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FDA 510(k)

FLUOROPERM 151-OK, PARAGON HDS 100-OK

K-Number: K010109 · 2001-02-28

ApplicantParagon Vision Sciences
Decision Date2001-02-28
Product CodeMUW
Advisory CommitteeOP
DecisionUnknown

Device Summary

FLUOROPERM 151-OK, PARAGON HDS 100-OK is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Vision Sciences. It received FDA 510(k) clearance on 2001-02-28 under 510(k) number K010109. The device is classified under product code MUW. It was reviewed by the OP advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the FLUOROPERM 151-OK, PARAGON HDS 100-OK?

FLUOROPERM 151-OK, PARAGON HDS 100-OK is a medical device that received FDA 510(k) clearance on 2001-02-28. The listed applicant is Paragon Vision Sciences. The 510(k) number is K010109.

When did FLUOROPERM 151-OK, PARAGON HDS 100-OK receive FDA 510(k) clearance?

FLUOROPERM 151-OK, PARAGON HDS 100-OK received FDA 510(k) clearance on 2001-02-28, under 510(k) number K010109.

Who is the listed applicant for FLUOROPERM 151-OK, PARAGON HDS 100-OK?

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

What is the FDA product code for FLUOROPERM 151-OK, PARAGON HDS 100-OK?

The FDA product code for FLUOROPERM 151-OK, PARAGON HDS 100-OK is MUW.

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Other records listing Paragon Vision Sciences 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.

K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEGK120996FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THINK082799HDS HI 1.54K070637FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSESK052983FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSESK013310PVS BASIC 2; EPIC 2

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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.K003933BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGYPolymer TechnologyK000224FLUROPERM 60-OK, PARAGON HDS-OKParagon Vision SciencesK973697AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGYAirperm, Inc.

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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