Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

Basic Information

• Brand Name: Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
• Primary DI: 00850007135690
• Version / Model: Emerald Elite
• Company Name: Euclid Vision Corporation
• Labeler DUNS: 969263979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-05
• Public Version: 1
• Public Version Date: 2025-08-13
• Public Version Status: New
• Public Device Record Key: 09e76851-22f1-4274-872f-4ae73b985fec

Device Description

Emerald Elite, tisilfocon A, Green

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic	886.5916	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47926	Orthokeratology contact lens	A rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007135690	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P040029	012