Name: Predicase
Price: 199 USD

K-number	K013365
Device name	PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
Applicant	Medical Bio Care Sweden AB
Product code	GEX
Device class	Class II
Decision date	Jan 8, 2002
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS

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