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FDA 510(k)

CERALAS DIODE LASER SYSTEM (MODEL H)

K-Number: K983950 · 1999-02-03

ApplicantCeram Optec, Inc.
Decision Date1999-02-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS DIODE LASER SYSTEM (MODEL H) is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1999-02-03 under 510(k) number K983950. 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 CERALAS DIODE LASER SYSTEM (MODEL H)?

CERALAS DIODE LASER SYSTEM (MODEL H) is a medical device that received FDA 510(k) clearance on 1999-02-03. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K983950.

When did CERALAS DIODE LASER SYSTEM (MODEL H) receive FDA 510(k) clearance?

CERALAS DIODE LASER SYSTEM (MODEL H) received FDA 510(k) clearance on 1999-02-03, under 510(k) number K983950.

Who is the listed applicant for CERALAS DIODE LASER SYSTEM (MODEL H)?

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

What is the FDA product code for CERALAS DIODE LASER SYSTEM (MODEL H)?

The FDA product code for CERALAS DIODE LASER SYSTEM (MODEL H) is GEX. This falls under the Gastroenterology category.

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Other records listing Ceram Optec, 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.

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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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