Name: Predicase
Price: 199 USD

K-number	K122213
Device name	ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant	Soflex Limited
Product code	LPL
Device class	Class II
Decision date	Dec 12, 2012
Decision	Substantially Equivalent
Regulation	886.5925

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 →

ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

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