Name: Predicase
Price: 199 USD

K-number	K211401
Device name	SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Applicant	Gyrus Acmi, Inc.
Product code	GEX
Device class	Class II
Decision date	Jun 3, 2021
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

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