FDA UDI
In Commercial Distribution
🇺🇸 United States
Rochester Optical
DI: 00860010085615
·
Model: RO-ML2-KIT
·
Vision Associates Of Rochester, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rochester Optical
- Primary DI
- 00860010085615
- Version / Model
- RO-ML2-KIT
- Company Name
- Vision Associates Of Rochester, Inc.
- Labeler DUNS
- 149453610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-10
- Public Version
- 1
- Public Version Date
- 2025-08-18
- Public Version Status
- New
- Public Device Record Key
- f38aa6cb-254d-4f41-92ec-5cbde5e9bb11
- Distribution End Date
- 2028-12-31
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35957 | Prescription spectacle lens, custom-made | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010085615 | GS1 |
Customer Contacts
- Phone
- 5859788816
- [email protected]