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FDA 510(k)

CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15

K-Number: K993002 · 1999-10-14

ApplicantCeram Optec, Inc.
Decision Date1999-10-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 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 1999-10-14 under 510(k) number K993002. 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 D 980NM DIODE LASER SYSTEM, MODEL D15?

CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 is a medical device that received FDA 510(k) clearance on 1999-10-14. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K993002.

When did CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 receive FDA 510(k) clearance?

CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 received FDA 510(k) clearance on 1999-10-14, under 510(k) number K993002.

Who is the listed applicant for CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15?

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 D 980NM DIODE LASER SYSTEM, MODEL D15?

The FDA product code for CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 is GEX. This falls under the Gastroenterology category.

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Other records listing Ceram Optec, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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