Name: Predicase
Price: 199 USD

K-number	K183200
Device name	iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
Applicant	C&E GP Specialist, Inc.
Product code	MUW
Device class	Class II
Decision date	Jan 9, 2019
Decision	Substantially Equivalent
Regulation	886.5916

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 →

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

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