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FDA 510(k)

ULTRASHAPER KERATOME

K-Number: K990227 · 2000-01-31

ApplicantLasersight Technologies, Inc.
Decision Date2000-01-31
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ULTRASHAPER KERATOME 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 2000-01-31 under 510(k) number K990227. 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 ULTRASHAPER KERATOME?

ULTRASHAPER KERATOME is a medical device that received FDA 510(k) clearance on 2000-01-31. The listed applicant is Lasersight Technologies, Inc.. The 510(k) number is K990227.

When did ULTRASHAPER KERATOME receive FDA 510(k) clearance?

ULTRASHAPER KERATOME received FDA 510(k) clearance on 2000-01-31, under 510(k) number K990227.

Who is the listed applicant for ULTRASHAPER KERATOME?

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 ULTRASHAPER KERATOME?

The FDA product code for ULTRASHAPER KERATOME 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 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.

K001144ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACSK974004AUTOMATED 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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