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FDA 510(k)

ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS

K-Number: K001144 · 2000-05-05

ApplicantLasersight Technologies, Inc.
Decision Date2000-05-05
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS is the device name listed in this FDA 510(k) record. The listed applicant is Lasersight Technologies, Inc.. It received FDA 510(k) clearance on 2000-05-05 under 510(k) number K001144. 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 ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS?

ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS is a medical device that received FDA 510(k) clearance on 2000-05-05. The listed applicant is Lasersight Technologies, Inc.. The 510(k) number is K001144.

When did ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS receive FDA 510(k) clearance?

ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS received FDA 510(k) clearance on 2000-05-05, under 510(k) number K001144.

Who is the listed applicant for ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS?

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

What is the FDA product code for ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS?

The FDA product code for ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS is HNO.

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Other records listing Lasersight Technologies, 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.

K990227ULTRASHAPER KERATOMEK974004AUTOMATED DISPOSABLE KERATOME (ADK)

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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