Name: Predicase
Price: 199 USD

K-number	K220222
Device name	IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
Applicant	Shenzhen Yuwei Electronic Technology Co., Ltd.
Product code	OHT
Device class	Class II
Decision date	Apr 26, 2022
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4

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