Diode Laser Hair Removal Machine (GLD01)
K-Number: K252427 · 2025-10-31
ApplicantSanhe Meditech Co., Ltd.
Decision Date2025-10-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode Laser Hair Removal Machine (GLD01) is a medical device manufactured by Sanhe Meditech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-31 under approval number K252427. 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 Hair Removal Machine (GLD01)?
Diode Laser Hair Removal Machine (GLD01) is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Sanhe Meditech Co., Ltd.. The 510(k) number is K252427.
When was Diode Laser Hair Removal Machine (GLD01) approved by the FDA?
Diode Laser Hair Removal Machine (GLD01) received FDA 510(k) clearance on 2025-10-31, under approval number K252427.
What company makes Diode Laser Hair Removal Machine (GLD01)?
Diode Laser Hair Removal Machine (GLD01) is manufactured by Sanhe Meditech Co., Ltd..
What is the FDA product code for Diode Laser Hair Removal Machine (GLD01)?
The FDA product code for Diode Laser Hair Removal Machine (GLD01) 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.