Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

GUDID 00850007135645

Emerald MAX, tisilfocon A, Blue

Euclid Vision Corporation

Orthokeratology contact lens

• Primary Device ID: 00850007135645
• NIH Device Record Key: 13daf3b6-6b57-409e-9ea3-b4fdd4d7d938
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
• Version Model Number: Emerald MAX
• Company DUNS: 969263979
• Company Name: Euclid Vision Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007135645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040029

FDA Product Code

• NUU: Lens, Contact, Orthokeratology, Overnight

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-13
• Device Publish Date: 2025-08-05

On-Brand Devices [Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear]

• 00850007135690: Emerald Elite, tisilfocon A, Green
• 00850007135683: Emerald MAX Toric, tisilfocon A, Green
• 00850007135676: Emerald MAX, tisilfocon A, Green
• 00850007135669: Emerald Elite, tisilfocon A, Blue
• 00850007135652: Emerald MAX Toric, tisilfocon A, Blue
• 00850007135645: Emerald MAX, tisilfocon A, Blue