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FDA 510(k)

RICROKERATOME BLADE

K-Number: K992978 · 1999-11-16

ApplicantSurgistar, Inc.
Decision Date1999-11-16
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RICROKERATOME BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Surgistar, Inc.. It received FDA 510(k) clearance on 1999-11-16 under 510(k) number K992978. 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 RICROKERATOME BLADE?

RICROKERATOME BLADE is a medical device that received FDA 510(k) clearance on 1999-11-16. The listed applicant is Surgistar, Inc.. The 510(k) number is K992978.

When did RICROKERATOME BLADE receive FDA 510(k) clearance?

RICROKERATOME BLADE received FDA 510(k) clearance on 1999-11-16, under 510(k) number K992978.

Who is the listed applicant for RICROKERATOME BLADE?

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

What is the FDA product code for RICROKERATOME BLADE?

The FDA product code for RICROKERATOME BLADE 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 Surgistar, 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.

K030891SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSKK941747SURGISTAR TROCARSK923689SURGISTAR BLADES

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

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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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