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L'Amy, Incorporated

US

Last updated May 24, 2026

What L'Amy, Incorporated makes

L'Amy, Incorporated manufactures tinted non-prescription spectacles under various brand names, including Nicole Miller, Champion, McLaren, and Ann Taylor. These products are designed for general eyewear use without requiring a prescription.

The company’s products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) database. 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 L'Amy, Incorporated manufacture?

L'Amy, Incorporated specializes in tinted non-prescription spectacles, which are designed for general eyewear use without requiring a prescription. These products are categorized under the FDA’s Class I medical device classification, indicating they pose minimal risk and are typically exempt from strict pre-market approval processes.

Where is L'Amy, Incorporated based, and what does that mean for its products?

L'Amy, Incorporated is based in the United States. This means its devices are subject to FDA regulations, including compliance with UDI (Unique Device Identification) requirements. The company’s products are listed in the FDA’s UDI database, ensuring traceability and regulatory transparency.

Which regulatory registries or databases list L'Amy, Incorporated’s devices?

L'Amy, Incorporated’s devices are included in the FDA’s Unique Device Identification (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring compliance with FDA mandates for transparency and traceability.

How are L'Amy, Incorporated’s devices classified under FDA regulations?

L'Amy, Incorporated’s products—specifically tinted non-prescription spectacles—are classified as FDA Class I medical devices. This classification is assigned based on risk assessment, where Class I devices are generally considered low-risk and often exempt from stringent pre-market approvals, though they still must comply with general controls.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
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Phone
2037610611
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
101332278

Catalogue (532)

Page 11 of 11
DeviceModel / ReferenceRegistriesClassStatus
Champion CU602904
FDA UDI
Class IActive
Champion CUGOALX02
FDA UDI
Class IActive
McLaren MLSEDS0304
FDA UDI
Class IActive
Nicole Miller NMPOLYNESIA01
FDA UDI
Class IActive
McLaren MLSUPS1701
FDA UDI
Class IActive
Champion CU516103
FDA UDI
Class IActive
McLaren MLGP-76S0403
FDA UDI
Class IActive
Champion CUFL600303
FDA UDI
Class IActive
Ann Taylor TYATP90703
FDA UDI
Class IActive
Champion CU603801
FDA UDI
Class IActive
McLaren MLSEDS0104
FDA UDI
Class IActive
Nicole Miller NMPUNTACANA02
FDA UDI
Class IActive
Champion CUFL606102
FDA UDI
Class IActive
Champion CU516401
FDA UDI
Class IActive
Champion CUFL606103
FDA UDI
Class IActive
McLaren MLMG-86S0401
FDA UDI
Class IActive
Nicole Miller NMSTRAND03
FDA UDI
Class IActive
McLaren MLGP-76S0402
FDA UDI
Class IActive
McLaren MLMS-85S0202
FDA UDI
Class IActive
Ann Taylor TYATP91502
FDA UDI
Class IActive
McLaren MLOP-98S0202
FDA UDI
Class IActive
Champion CU516604
FDA UDI
Class IActive
McLaren MLSEDS0404
FDA UDI
Class IActive
McLaren MLSUPS19C04
FDA UDI
Class IActive
McLaren MLSUPS2003
FDA UDI
Class IActive
Ann Taylor TYATP92402
FDA UDI
Class IActive
Ann Taylor TYATP92303
FDA UDI
Class IActive
Ann Taylor TYATP92301
FDA UDI
Class IActive
Champion CUSTEADYX02
FDA UDI
Class IActive
McLaren MLMS-85S0401
FDA UDI
Class IActive
McLaren MLMS-85S0203
FDA UDI
Class IActive
Sperry SPBLUFFPOINT03
FDA UDI
Class IActive

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