Name: Predicase
Price: 199 USD

K-number	K214101
Device name	Project E Beauty LED Light Therapy Mask (Model: PE730)
Applicant	Duplex International Trading Limited
Product code	OHS
Device class	Class II
Decision date	Mar 23, 2022
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Project E Beauty LED Light Therapy Mask (Model: PE730)

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