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	Burnham-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Albers-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Haussmann-Cyprss	FDA UDI	Class I	Active
Blake Kuwahara	BK1014-Grey Fade-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Albers-Brown Hrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1012-Mauve-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Stanton-Mtte Blk	FDA UDI	Class I	Active
Blake Kuwahara	Chambers-Ghost	FDA UDI	Class I	Active
Blake Kuwahara	Curlett-Sakura	FDA UDI	Class I	Active
Blake Kuwahara	Bardi-Brushed Black	FDA UDI	Class I	Active
Blake Kuwahara	Kesling-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Lina-Plum	FDA UDI	Class I	Active
Blake Kuwahara	BK1019-Gold-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Crystal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1020-Black/Blu	FDA UDI	Class I	Active
Blake Kuwahara	Landis-Flint	FDA UDI	Class I	Active
Blake Kuwahara	Mackintosh-Topaz	FDA UDI	Class I	Active
Blake Kuwahara	BK1019-White	FDA UDI	Class I	Active
Blake Kuwahara	BK1015-Olive	FDA UDI	Class I	Active
Blake Kuwahara	Stanton-Gold-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Bowman-Sky Weave	FDA UDI	Class I	Active
Blake Kuwahara	BK1006-Gunmetal	FDA UDI	Class I	Active
Blake Kuwahara	Paley-Sea-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Crystal	FDA UDI	Class I	Active
Blake Kuwahara	BK1012-Brwn Strw	FDA UDI	Class I	Active
Blake Kuwahara	Franzen-Hickory	FDA UDI	Class I	Active
Blake Kuwahara	Stanton-Antq Ptr-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Conklin-Sable	FDA UDI	Class I	Active
Blake Kuwahara	Reed-Umber-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1010-Surf	FDA UDI	Class I	Active
Blake Kuwahara	Bowman-Cranberry-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Hall-Amber Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Belgm Blu-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Fletcher-LtBrnHrn-Sn	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Nvy Weave	FDA UDI	Class I	Active
Blake Kuwahara	Alsop-Bark	FDA UDI	Class I	Active
Blake Kuwahara	BK1010-Leaf	FDA UDI	Class I	Active
Blake Kuwahara	Lutynes-Cranbrry-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Pelham-Crystal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Wells-Nude	FDA UDI	Class I	Active
Blake Kuwahara	Nelson-Ocean	FDA UDI	Class I	Active
Blake Kuwahara	Pei-Crystal	FDA UDI	Class I	Active
Blake Kuwahara	Alsop-Bark-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1013-Black	FDA UDI	Class I	Active
Blake Kuwahara	Venturi-Hickory-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Buff-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	BK1018-Gold-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Findley-Wht Strp	FDA UDI	Class I	Active
Blake Kuwahara	Frey-Crystal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Reed-Midnight	FDA UDI	Class I	Active

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