Name: Predicase
Price: 199 USD

K-number	K251303
Device name	Tamburo Thulium Fiber Laser System
Applicant	Menovex Medical Technology (Shenzhen) Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Nov 4, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Tamburo Thulium Fiber Laser System

Everything you need for a 510(k) submission. Nothing you don't.