Name: Predicase
Price: 199 USD

K-number	K251919
Device name	Thulium Laser System (Deluxlase)
Applicant	Nanjing Bestview Laser S&T Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Sep 26, 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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Thulium Laser System (Deluxlase)

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