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FDA 510(k)

KERATOLUX

K-Number: K854383 · 1985-11-12

ApplicantCarl Zeiss, Inc.
Decision Date1985-11-12
Product CodeHPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KERATOLUX is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K854383. The device is classified under product code HPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERATOLUX?

KERATOLUX is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K854383.

When did KERATOLUX receive FDA 510(k) clearance?

KERATOLUX received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854383.

Who is the listed applicant for KERATOLUX?

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

What is the FDA product code for KERATOLUX?

The FDA product code for KERATOLUX is HPL.

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Other records listing Carl Zeiss, Inc. as applicant

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Related Devices (Code: HPL)

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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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