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FDA 510(k)

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

K-Number: K020099 · 2002-04-11

ApplicantBiolitec, Inc.
Decision Date2002-04-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2002-04-11 under 510(k) number K020099. 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 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE?

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE is a medical device that received FDA 510(k) clearance on 2002-04-11. The listed applicant is Biolitec, Inc.. The 510(k) number is K020099.

When did MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE receive FDA 510(k) clearance?

MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE received FDA 510(k) clearance on 2002-04-11, under 510(k) number K020099.

Who is the listed applicant for MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE?

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

What is the FDA product code for MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE?

The FDA product code for MEGA BEAM/CERALAS NONSTERILE 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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