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FDA 510(k)

CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.

K-Number: K883738 · 1988-11-15

ApplicantDirected Energy, Inc.
Decision Date1988-11-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1988-11-15 under 510(k) number K883738. 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 CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.?

CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. is a medical device that received FDA 510(k) clearance on 1988-11-15. The listed applicant is Directed Energy, Inc.. The 510(k) number is K883738.

When did CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. receive FDA 510(k) clearance?

CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. received FDA 510(k) clearance on 1988-11-15, under 510(k) number K883738.

Who is the listed applicant for CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.?

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

What is the FDA product code for CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.?

The FDA product code for CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. is GEX. This falls under the Gastroenterology category.

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Other records listing Directed Energy, Inc. as applicant

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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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