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FDA 510(k)

FIBEROPTIC COLLIMATING HANDPIECE

K-Number: K854134 · 1986-02-07

ApplicantDawn Laser Technology, Inc.
Decision Date1986-02-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FIBEROPTIC COLLIMATING HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Dawn Laser Technology, Inc.. It received FDA 510(k) clearance on 1986-02-07 under 510(k) number K854134. 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 FIBEROPTIC COLLIMATING HANDPIECE?

FIBEROPTIC COLLIMATING HANDPIECE is a medical device that received FDA 510(k) clearance on 1986-02-07. The listed applicant is Dawn Laser Technology, Inc.. The 510(k) number is K854134.

When did FIBEROPTIC COLLIMATING HANDPIECE receive FDA 510(k) clearance?

FIBEROPTIC COLLIMATING HANDPIECE received FDA 510(k) clearance on 1986-02-07, under 510(k) number K854134.

Who is the listed applicant for FIBEROPTIC COLLIMATING HANDPIECE?

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

What is the FDA product code for FIBEROPTIC COLLIMATING HANDPIECE?

The FDA product code for FIBEROPTIC COLLIMATING HANDPIECE is GEX. This falls under the Gastroenterology category.

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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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