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FDA 510(k)

MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG

K-Number: K862408 · 1986-10-24

ApplicantDirected Energy, Inc.
Decision Date1986-10-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG 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 1986-10-24 under 510(k) number K862408. 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 MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG?

MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Directed Energy, Inc.. The 510(k) number is K862408.

When did MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG receive FDA 510(k) clearance?

MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG received FDA 510(k) clearance on 1986-10-24, under 510(k) number K862408.

Who is the listed applicant for MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG?

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 MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG?

The FDA product code for MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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