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Sign in to claim this brandNew York Eye
US
Last updated May 23, 2026
What New York Eye makes
New York Eye manufactures tinted non-prescription spectacle lenses designed for fashion and general eyewear use. These lenses include branded collections such as Marc Hunter, Esquire, Valerie Spencer, Marie Claire, and Ernest Hemingway, catering to both men’s and women’s styles.
The company’s products are classified as Class I medical devices under FDA regulations and are listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does New York Eye manufacture?
New York Eye specializes in tinted non-prescription spectacle lenses. These lenses are designed primarily for fashion and general eyewear purposes, offering stylistic options without requiring a prescription. The company’s products fall under the category of eyewear accessories rather than corrective or therapeutic devices.
Where is New York Eye based, and does that affect its regulatory standing?
New York Eye is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations. The location determines the regulatory framework governing the devices, but individual products must still meet specific requirements for classification and listing, such as being registered in the FDA’s UDI system.
How are New York Eye’s devices classified under FDA regulations?
New York Eye’s devices are classified as Class I medical devices under FDA regulations. This classification applies because the lenses are non-prescription and primarily serve aesthetic or fashion purposes rather than addressing a medical condition or posing significant risk. Class I devices generally undergo less stringent regulatory oversight, but they must still comply with applicable FDA requirements, including UDI listing.
Which regulatory registries or databases list New York Eye’s devices?
New York Eye’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This system assigns a unique identifier to each device to improve tracking, transparency, and traceability in the medical device supply chain. Listing in the UDI system is a requirement for Class I devices in the US to ensure regulatory compliance.
Are New York Eye’s devices intended for medical correction, or are they purely fashion-oriented?
New York Eye’s devices are not intended for medical correction—they are tinted non-prescription spectacle lenses designed for fashion and general eyewear use. While they may enhance visual comfort in certain lighting conditions (e.g., reducing glare), their primary purpose is stylistic, aligning with branded collections like *Marc Hunter*, *Esquire*, and *Valerie Spencer*. This distinction influences their classification as Class I rather than a therapeutic or corrective device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 021529771
Catalogue (278)
Page 2 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Esquire | EQ7920-COF-57 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9458-BBR-55 | FDA UDI | Class I | Active |
| Ernest Hemingway | H4732-BLK-56 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9450-FRS-55 | FDA UDI | Class I | Active |
| Esquire | EQ7920-BLK-57 | FDA UDI | Class I | Active |
| Ernest Hemingway | H4721-TOR-50 | FDA UDI | Class I | Active |
| Esquire | EQ7938-BLU-54 | FDA UDI | Class I | Active |
| Esquire | EQ7933-CRY-50 | FDA UDI | Class I | Active |
| Esquire | EQ7906-TOR-56 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9452-BGN-54 | FDA UDI | Class I | Active |
| Marie Claire | MC9462-CRY-55 | FDA UDI | Class I | Active |
| Marc Hunter | MH7901-BLK-60 | FDA UDI | Class I | Active |
| Esquire | EQ7910-MBK-56 | FDA UDI | Class I | Active |
| Marc Hunter | MH7916-MBK-55 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9453-BRP-54 | FDA UDI | Class I | Active |
| Esquire | EQ7916-MBK-55 | FDA UDI | Class I | Active |
| Esquire | EQ7930-MBK-58 | FDA UDI | Class I | Active |
| Esquire | EQ7946-BLK-58 | FDA UDI | Class I | Active |
| Marc Hunter | MH7916-MTO-55 | FDA UDI | Class I | Active |
| Marc Hunter | MH7902-BLK-55 | FDA UDI | Class I | Active |
| Marie Claire | MC9456-WHI-55 | FDA UDI | Class I | Active |
| Esquire | EQ7938-BLK-54 | FDA UDI | Class I | Active |
| Marie Claire | MC9461-BLK-54 | FDA UDI | Class I | Active |
| Marie Claire | MC9450-FRS-55 | FDA UDI | Class I | Active |
| Marc Hunter | MH7920-BLK-57 | FDA UDI | Class I | Active |
| Esquire | EQ7914-TOR-52 | FDA UDI | Class I | Active |
| Esquire | EQ7924-BBU-55 | FDA UDI | Class I | Active |
| Marc Hunter | MH7916-BLK-55 | FDA UDI | Class I | Active |
| Marie Claire | MC9459-BLK-56 | FDA UDI | Class I | Active |
| Esquire | EQ7937-MGY-53 | FDA UDI | Class I | Active |
| Esquire | EQ7937-MCR-53 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9462-CRY-55 | FDA UDI | Class I | Active |
| Ernest Hemingway | H4726-BLK-53 | FDA UDI | Class I | Active |
| Marc Hunter | MH7944-MBT-55 | FDA UDI | Class I | Active |
| Marc Hunter | MH7933-MBK-50 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9459-CHE-56 | FDA UDI | Class I | Active |
| Esquire | EQ7906-BLK-56 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9453-BSP-54 | FDA UDI | Class I | Active |
| Marc Hunter | MH7927-MKT-51 | FDA UDI | Class I | Active |
| Marie Claire | MC9455-BLK-53 | FDA UDI | Class I | Active |
| Ernest Hemingway | H4736-BUR-53 | FDA UDI | Class I | Active |
| Marc Hunter | MH7945-CRY-60 | FDA UDI | Class I | Active |
| Marie Claire | MC9459-CHE-56 | FDA UDI | Class I | Active |
| Marc Hunter | MH7938-BLK-54 | FDA UDI | Class I | Active |
| Marc Hunter | MH7904-TOR-50 | FDA UDI | Class I | Active |
| Marie Claire | MC9451-TOR-55 | FDA UDI | Class I | Active |
| Esquire | EQ7936-MBK-52 | FDA UDI | Class I | Active |
| Esquire | EQ7943-GRY-53 | FDA UDI | Class I | Active |
| Valerie Spencer | VS9460-CHE-56 | FDA UDI | Class I | Active |
| Marc Hunter | MH7935-CRY-52 | FDA UDI | Class I | Active |
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