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FDA 510(k)

REFRACTIVE SURGERY BLADES

K-Number: K001806 · 2000-09-12

ApplicantMillennium Biomedical, Inc.
Decision Date2000-09-12
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

REFRACTIVE SURGERY BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Millennium Biomedical, Inc.. It received FDA 510(k) clearance on 2000-09-12 under 510(k) number K001806. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFRACTIVE SURGERY BLADES?

REFRACTIVE SURGERY BLADES is a medical device that received FDA 510(k) clearance on 2000-09-12. The listed applicant is Millennium Biomedical, Inc.. The 510(k) number is K001806.

When did REFRACTIVE SURGERY BLADES receive FDA 510(k) clearance?

REFRACTIVE SURGERY BLADES received FDA 510(k) clearance on 2000-09-12, under 510(k) number K001806.

Who is the listed applicant for REFRACTIVE SURGERY BLADES?

The FDA 510(k) record lists Millennium Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFRACTIVE SURGERY BLADES?

The FDA product code for REFRACTIVE SURGERY BLADES is HNO.

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 Millennium Biomedical, Inc. 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.

K041110MB 105 MILLENNIUM BLADESK020122MB 102 MILLENNIUM BLADESK011833MB 103 MILLENNIUM BLADESK003143MILLENNIUM BLADES, MODEL MB101

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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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