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FDA 510(k)

SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK

K-Number: K030891 · 2003-06-17

ApplicantSurgistar, Inc.
Decision Date2003-06-17
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK is the device name listed in this FDA 510(k) record. The listed applicant is Surgistar, Inc.. It received FDA 510(k) clearance on 2003-06-17 under 510(k) number K030891. 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 SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK?

SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK is a medical device that received FDA 510(k) clearance on 2003-06-17. The listed applicant is Surgistar, Inc.. The 510(k) number is K030891.

When did SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK receive FDA 510(k) clearance?

SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK received FDA 510(k) clearance on 2003-06-17, under 510(k) number K030891.

Who is the listed applicant for SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK?

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 SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK?

The FDA product code for SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK is HNO.

Related Clinical Trials

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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.

K992978RICROKERATOME BLADEK941747SURGISTAR 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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