Name: Predicase
Price: 199 USD

K-number	K033655
Device name	SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
Applicant	Soflex Contact Lens Industries , Ltd.
Product code	LPL
Device class	Class II
Decision date	Jul 30, 2004
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 →

SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR

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