Name: Predicase
Price: 199 USD

K-number	K161394
Device name	HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Applicant	Sportarredo Group S.C.
Product code	LEJ
Device class	Class II
Decision date	Jul 6, 2017
Decision	Substantially Equivalent
Regulation	878.4635

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 →

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

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