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FDA 510(k)

ZEISS DIODE-PUMPED SOLID STATE LASER

K-Number: K925642 · 1993-09-13

ApplicantCarl Zeiss, Inc.
Decision Date1993-09-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZEISS DIODE-PUMPED SOLID STATE LASER 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 1993-09-13 under 510(k) number K925642. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEISS DIODE-PUMPED SOLID STATE LASER?

ZEISS DIODE-PUMPED SOLID STATE LASER is a medical device that received FDA 510(k) clearance on 1993-09-13. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K925642.

When did ZEISS DIODE-PUMPED SOLID STATE LASER receive FDA 510(k) clearance?

ZEISS DIODE-PUMPED SOLID STATE LASER received FDA 510(k) clearance on 1993-09-13, under 510(k) number K925642.

Who is the listed applicant for ZEISS DIODE-PUMPED SOLID STATE LASER?

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 ZEISS DIODE-PUMPED SOLID STATE LASER?

The FDA product code for ZEISS DIODE-PUMPED SOLID STATE LASER is GEX. This falls under the Gastroenterology category.

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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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