Rochester Optical

Primary DI
00860010085615
Brand
Rochester Optical
Company
Vision Associates Of Rochester, Inc.
Model
RO-ML2-KIT
Device 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
Published
2025-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010085615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010085615008600100856158600100856150860010085615

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectacle lens, custom-madeAn ophthalmic lens made of glass or plastic that is manufactured in accordance with a specific patient prescription (custom-made) and intended to be worn in front of the eyes to correct the refractive errors of that patient's eyesight, e.g., refractive ametropia (myopia, hyperopia and astigmatism), and possibly to protect the eyes against radiation or mechanical hazards; it has no additional specialized features. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5859788816sam.chen@rochesteroptical.com

Regulatory Flags#

DUNS number
149453610
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true