Name: Predicase
Price: 199 USD

K-number	K192585
Device name	Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap
Applicant	Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
Product code	OAP
Device class	Class II
Decision date	Jan 29, 2020
Decision	Substantially Equivalent
Regulation	890.5500

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

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