Question 1

What types of medical devices does Fade To Grey Corp. manufacture?

Accepted Answer

Fade To Grey Corp. specializes in spectacle frames and tinted non-prescription spectacles. These devices are intended for general eyewear use without prescription modifications, including options like the Blake Kuwahara line. The company focuses on non-invasive, low-risk products designed for everyday vision correction.

Question 2

Where is Fade To Grey Corp. based, and how does that affect its regulatory standing?

Accepted Answer

Fade To Grey Corp. is based in the United States. Since its devices are classified as Class I under FDA regulations, they are subject to the least stringent controls among medical devices. This classification applies globally when marketed in the US, meaning the company must comply with FDA requirements for listing in the UDI database but does not require pre-market approval for these specific products.

Question 3

Which regulatory registries or databases list Fade To Grey Corp.’s devices?

Accepted Answer

Fade To Grey Corp.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, which are exempt from pre-market approval but still require identification and reporting under FDA guidelines. The UDI system helps track devices throughout their lifecycle.

Question 4

How are Fade To Grey Corp.’s devices classified under FDA regulations?

Accepted Answer

Fade To Grey Corp.’s spectacle frames and tinted non-prescription spectacles fall under Class I classification by the FDA. This classification is assigned to devices posing minimal risk to users, such as general eyewear without active components or invasive procedures. Class I devices typically undergo general controls (e.g., manufacturing practices, labeling) rather than pre-market review, reflecting their low-risk nature.

Question 5

Are Fade To Grey Corp.’s devices intended for prescription use, or are they non-prescription?

Accepted Answer

Fade To Grey Corp.’s devices, including the Blake Kuwahara line, are non-prescription spectacles. They are designed for general vision correction without requiring an optometrist’s or ophthalmologist’s prescription, focusing on aesthetic and functional eyewear for everyday use. This distinction aligns with their Class I classification, as they do not involve medical interventions.

Device	Model / Reference	Registries	Class	Status
Blake Kuwahara	Delano-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Lifesaver-Azure	FDA UDI	Class I	Active
Blake Kuwahara	Frey-Grape	FDA UDI	Class I	Active
Blake Kuwahara	Deaton-Grey Fade-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Webster-Tobacco-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1006-Matte Blk	FDA UDI	Class I	Active
Blake Kuwahara	BK1010-Cloud	FDA UDI	Class I	Active
Blake Kuwahara	Bigr Blore-Gry Fd-Sn	FDA UDI	Class I	Active
Blake Kuwahara	Venturi-Ink-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Graphite	FDA UDI	Class I	Active
Blake Kuwahara	Albers-Indgo Hrn	FDA UDI	Class I	Active
Blake Kuwahara	Kesling-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Skinner-Red Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Landis-Flint-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Ellwood-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1014-Grey Fade	FDA UDI	Class I	Active
Blake Kuwahara	Bigr Blore-BrnHrn-Sn	FDA UDI	Class I	Active
Blake Kuwahara	BK1016-Grey Fade	FDA UDI	Class I	Active
Blake Kuwahara	Roloff-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Bowman-Brshd Blk-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Ellwood-Navy-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1014-BrshBrnHrn	FDA UDI	Class I	Active
Blake Kuwahara	BK1006-Matte Blk-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Chambers-Teal	FDA UDI	Class I	Active
Blake Kuwahara	Fletcher-LtBrnHrn	FDA UDI	Class I	Active
Blake Kuwahara	Bigr Blore-Midnt	FDA UDI	Class I	Active
Blake Kuwahara	BK1012-Snake	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Belgm Blu	FDA UDI	Class I	Active
Blake Kuwahara	BK1018-White	FDA UDI	Class I	Active
Blake Kuwahara	Buff-Cypress-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Haussmann-Crystl	FDA UDI	Class I	Active
Blake Kuwahara	Chambers-Pride	FDA UDI	Class I	Active
Blake Kuwahara	Pelham-Crystal	FDA UDI	Class I	Active
Blake Kuwahara	BK1011-Mocha	FDA UDI	Class I	Active
Blake Kuwahara	BK1016-Carml Fde-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Paley-Sea	FDA UDI	Class I	Active
Blake Kuwahara	Skinner-Crystal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Conklin-Rosewood	FDA UDI	Class I	Active
Blake Kuwahara	Venturi-Hickory	FDA UDI	Class I	Active
Blake Kuwahara	Cobb-Taupe-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1006-Gold-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Emmons-Barley-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1014-BrshBrnHrnSun	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Blossom	FDA UDI	Class I	Active
Blake Kuwahara	Cody-Bark	FDA UDI	Class I	Active
Blake Kuwahara	Franzen-Hickory-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Kesling-Rust-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Nelson-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Findley-Blk Web-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Gaudi-Pecan	FDA UDI	Class I	Active

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