Rochester Optical

FDA UDI

by Vision Associates of Rochester, Inc.

Identity

Trade Name: Rochester Optical FDA UDI
Generic Name: Prescription spectacle lens, custom-made FDA UDI
Device Name: 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 FDA UDI
Model / Reference: RO-ML2-KIT FDA UDI
Description: 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860010085615 FDA UDI
GMDN Term: Prescription spectacle lens, custom-made FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Prescription spectacle lens, custom-made

Rochester Optical by Vision Associates of Rochester, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prescription spectacle lens, custom-made.

ZEISS Optical Inserts — Carl Zeiss Vision International GmbH · Class I
ZEISS Optical Insert- Reader — Carl Zeiss Vision International GmbH · Class I
ZEISS Optical Inserts — Carl Zeiss Vision International GmbH · Class I
ZEISS Optical Insert - Demo — Carl Zeiss Vision International GmbH · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Vision Associates of Rochester, Inc.

Sources (1)

FDA UDI f38aa6cb-254d-4f41-92ec-5cbde5e9bb11 35 fields · synced Jun 8, 2026