Diode Laser System model Dawn-S
K-Number: K243037 · 2024-12-26
Decision Date2024-12-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser System model Dawn-S is a medical device manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2024-12-26 under approval number K243037. 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 Diode Laser System model Dawn-S?
Diode Laser System model Dawn-S is a medical device that received FDA 510(k) clearance on 2024-12-26. It is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K243037.
When was Diode Laser System model Dawn-S approved by the FDA?
Diode Laser System model Dawn-S received FDA 510(k) clearance on 2024-12-26, under approval number K243037.
What company makes Diode Laser System model Dawn-S?
Diode Laser System model Dawn-S is manufactured by Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd.
What is the FDA product code for Diode Laser System model Dawn-S?
The FDA product code for Diode Laser System model Dawn-S is GEX. This falls under the Gastroenterology category.
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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.