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FDA 510(k)

Global Med Systems Milesman Compact Laser

K-Number: K203804 · 2021-02-23

ApplicantGlobal Med Systems SL
Decision Date2021-02-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Global Med Systems Milesman Compact Laser is a medical device manufactured by Global Med Systems SL. It received FDA 510(k) clearance on 2021-02-23 under approval number K203804. 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 Global Med Systems Milesman Compact Laser?

Global Med Systems Milesman Compact Laser is a medical device that received FDA 510(k) clearance on 2021-02-23. It is manufactured by Global Med Systems SL. The 510(k) number is K203804.

When was Global Med Systems Milesman Compact Laser approved by the FDA?

Global Med Systems Milesman Compact Laser received FDA 510(k) clearance on 2021-02-23, under approval number K203804.

What company makes Global Med Systems Milesman Compact Laser?

Global Med Systems Milesman Compact Laser is manufactured by Global Med Systems SL.

What is the FDA product code for Global Med Systems Milesman Compact Laser?

The FDA product code for Global Med Systems Milesman Compact Laser is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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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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