Rochester Optical

GUDID 00860010085615

The registered product is a lens kit, which includes EIGHT (8) inserts in pre-determined diopters (+1.50D, -1.0D, -1.50D, -2.0D, -2.50D. -3.0D, -4.0D, and -5.0D) with a pupillary distance of 65mm. They are not made to any user’s prescription. Their intent is to provide wearers of Magic Leap 2 smart glasses with a quick vision solution, typically in a demo or tradeshow scenario. The product is exclusively designed to work with Magic Leap 2 smart glasses to help prescription eyeglasses wearers to view the augmented reality display with corrective lenses

Vision Associates Of Rochester, Inc.

Prescription spectacle lens, custom-made

• Primary Device ID: 00860010085615
• NIH Device Record Key: f38aa6cb-254d-4f41-92ec-5cbde5e9bb11
• Commercial Distribution Discontinuation: 2028-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rochester Optical
• Version Model Number: RO-ML2-KIT
• Company DUNS: 149453610
• Company Name: Vision Associates Of Rochester, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com
• Phone: 5859788816
• Email: sam.chen@rochesteroptical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010085615 [Primary]

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: 2025-08-18
• Device Publish Date: 2025-08-10