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	BK1015-Matte Blk	FDA UDI	Class I	Active
Blake Kuwahara	Fletcher-Olive	FDA UDI	Class I	Active
Blake Kuwahara	BK1020-Black/Blu-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Mackintosh-Grnet	FDA UDI	Class I	Active
Blake Kuwahara	Skinner-Brook-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Webster-Brwn Hrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Portman-Blue Hrn	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Vilet Wve-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Blore-Ocean-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Delano-Olive Hrn	FDA UDI	Class I	Active
Blake Kuwahara	BK1005-White	FDA UDI	Class I	Active
Blake Kuwahara	Stanton-Gold	FDA UDI	Class I	Active
Blake Kuwahara	Bowman-Brshd Blk	FDA UDI	Class I	Active
Blake Kuwahara	Pelham-Blue	FDA UDI	Class I	Active
Blake Kuwahara	BK1019-Red	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Topaz-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Skinner-Brook	FDA UDI	Class I	Active
Blake Kuwahara	Lutynes-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Deaton-Grey Fade	FDA UDI	Class I	Active
Blake Kuwahara	BK1015-Eggplant	FDA UDI	Class I	Active
Blake Kuwahara	Roloff-Navy-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Deaton-Brown Hrn	FDA UDI	Class I	Active
Blake Kuwahara	BK1019-Antq Pwtr-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Mackintosh-Junpr	FDA UDI	Class I	Active
Blake Kuwahara	Merrill-Crystal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Delano-Blue Horn	FDA UDI	Class I	Active
Blake Kuwahara	Merrill-MthrOfPrl-Sn	FDA UDI	Class I	Active
Blake Kuwahara	Delano-Frost	FDA UDI	Class I	Active
Blake Kuwahara	Roloff-Olive	FDA UDI	Class I	Active
Blake Kuwahara	Deaton-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1020-Violt/Pnk-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Frey-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Mackintosh-Topaz-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Flint	FDA UDI	Class I	Active
Blake Kuwahara	Fletcher-Mdnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Portman-LtGryHrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1008-Navy Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Black-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Gaudi-Blue Grass-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Nelson-Bark-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Pei-Gravel Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1008-Black Hrn	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Blossom-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Paley-Taupe-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Venturi-Gry Fade-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Webster-Slate Horn	FDA UDI	Class I	Active
Blake Kuwahara	Wells-Berry	FDA UDI	Class I	Active
Blake Kuwahara	Hall-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Blore-Brown Horn	FDA UDI	Class I	Active
Blake Kuwahara	Nelson-Grey Horn	FDA UDI	Class I	Active

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