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FDA 510(k)

PLANCON MICROLAMELLAR KERATOME EVOLUTION

K-Number: K980924 · 1998-04-15

ApplicantPlancon Instruments
Decision Date1998-04-15
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PLANCON MICROLAMELLAR KERATOME EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Plancon Instruments. It received FDA 510(k) clearance on 1998-04-15 under 510(k) number K980924. 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 PLANCON MICROLAMELLAR KERATOME EVOLUTION?

PLANCON MICROLAMELLAR KERATOME EVOLUTION is a medical device that received FDA 510(k) clearance on 1998-04-15. The listed applicant is Plancon Instruments. The 510(k) number is K980924.

When did PLANCON MICROLAMELLAR KERATOME EVOLUTION receive FDA 510(k) clearance?

PLANCON MICROLAMELLAR KERATOME EVOLUTION received FDA 510(k) clearance on 1998-04-15, under 510(k) number K980924.

Who is the listed applicant for PLANCON MICROLAMELLAR KERATOME EVOLUTION?

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

What is the FDA product code for PLANCON MICROLAMELLAR KERATOME EVOLUTION?

The FDA product code for PLANCON MICROLAMELLAR KERATOME EVOLUTION 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 Plancon Instruments 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.

K970377PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)K960395PLANCON MIRCOLAMELLAR 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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