EnChroma®
- Primary DI
- 00810750031823
- Brand
- EnChroma®
- Company
- Enchroma Inc.
- Model
- Lx Series Professional Demo Kit
- Device description
- The EnChroma Lx Series Professional Demo Kit for low vision and age-related eye conditions is a trial set of four unique, high performance EnChroma lenses in a convenient tray. Each Lx lens option is scientifically tuned to maximize visual comfort and to address a range of visual challenges experienced by patients with low vision or aging eyes. Each of the carefully curated lenses are delivered in convenient fit-over frames for easy in-office trial. Included with the kit is a Lx Series Dispensing Mat to assist in selection and as a teaching tool with patients. All Lx Series lenses offer 100% UV protection and blue light filtering. Kit Contents include: Fit-over Lx1 Light Amber (80%T), Fit-over Lx2 Copper (12%T), Fit-over Lx3 Chestnut (36%T), Fit-over Lx4 Deep Chestnut (3%T). EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma Lx Series lenses and eyewear are intended for use by people with low vision, age-related eye conditions, or other visual impairments to enhance color vision and to reduce glare from bright light. EnChroma eyewear are not suitable for driving and road use. Tinted lenses may impair visibility in low light conditions and should not be used for driving in twilight, night, or through tunnels. Eyewear designed for glare reduction may reduce the discomfort from glare but may not improve visibility in glare conditions. EnChroma Lx Series eyewear are an optical assistive device and are not intended to treat or cure any visual impairment or any other medical condition, such as photosensitive epilepsy. Store in a cool, dry area away from extreme temperatures as it can damage the lenses. DO NOT store the glasses inside hot vehicles.
- Published
- 2022-12-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810750031823 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810750031823 | 00810750031823 | 810750031823 | 0810750031823 |
GMDN Terms
| Term | Definition |
|---|
| Colour discrimination non-prescription spectacles | An ophthalmic device consisting of a spectacle frame with a pair of coloured/tinted lenses (non-refractive) designed to be worn in front of the patient’s eyes to enhance colour discrimination in patients with colour vision deficiency; it is not intended to correct refractive vision conditions and is not customized for a specific patient. |
Regulatory Flags
- DUNS number
- 963464198
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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