Name: Predicase
Price: 199 USD

K-number	K240456
Device name	Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
Applicant	Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
Product code	OAP
Device class	Class II
Decision date	May 22, 2024
Decision	Substantially Equivalent
Regulation	890.5500

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Source

View the full FDA submission: accessdata.fda.gov

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Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

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