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FDA 510(k)

AUTOMATED DISPOSABLE KERATOME (ADK)

K-Number: K974004 · 1998-01-08

ApplicantLasersight Technologies, Inc.
Decision Date1998-01-08
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATED DISPOSABLE KERATOME (ADK) 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 1998-01-08 under 510(k) number K974004. 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 AUTOMATED DISPOSABLE KERATOME (ADK)?

AUTOMATED DISPOSABLE KERATOME (ADK) is a medical device that received FDA 510(k) clearance on 1998-01-08. The listed applicant is Lasersight Technologies, Inc.. The 510(k) number is K974004.

When did AUTOMATED DISPOSABLE KERATOME (ADK) receive FDA 510(k) clearance?

AUTOMATED DISPOSABLE KERATOME (ADK) received FDA 510(k) clearance on 1998-01-08, under 510(k) number K974004.

Who is the listed applicant for AUTOMATED DISPOSABLE KERATOME (ADK)?

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 AUTOMATED DISPOSABLE KERATOME (ADK)?

The FDA product code for AUTOMATED DISPOSABLE KERATOME (ADK) 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 - ACSK990227ULTRASHAPER KERATOME

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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