Name: Predicase
Price: 199 USD

K-number	K252519
Device name	CO2 Laser Therapy System (K106)
Applicant	Hebei Keylaser Sci-Tech Co.,Ltd
Product code	GEX
Device class	Class II
Decision date	Nov 7, 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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CO2 Laser Therapy System (K106)

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