Name: Predicase
Price: 199 USD

K-number	K252345
Device name	Picosecond Laser Device (PF131-BI)
Applicant	Risu Medical Technology Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Oct 23, 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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Picosecond Laser Device (PF131-BI)

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