Name: Predicase
Price: 199 USD

K-number	K221712
Device name	Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
Applicant	Fotona D.O.O.
Product code	GEX
Device class	Class II
Decision date	Oct 12, 2022
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

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