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	BK1011-Rhino-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Reed-Brown Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Burnham-Hickory	FDA UDI	Class I	Active
Blake Kuwahara	Bigr Blore-Gry Fd	FDA UDI	Class I	Active
Blake Kuwahara	BK1013-Ant Pewtr	FDA UDI	Class I	Active
Blake Kuwahara	BK1019-Red-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Paley-Reed-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Hall-Forest-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1020-Brgndy/Rd-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Pei-Gravel Horn	FDA UDI	Class I	Active
Blake Kuwahara	Delano-Olive Hrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1005-Black	FDA UDI	Class I	Active
Blake Kuwahara	BK1015-Matte Blk-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1015-Rose Gold-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1011-Sage	FDA UDI	Class I	Active
Blake Kuwahara	Cody-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Franzen-Shadow-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Wells-Nude-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1011-Sage-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Owings-Graphite	FDA UDI	Class I	Active
Blake Kuwahara	BK1018-Shiny Blk-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Gaudi-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Gaudi-Sangria-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Venturi-Sparrow-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1019-White-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Brown Hrn	FDA UDI	Class I	Active
Blake Kuwahara	BK1014-Brwn Fade-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Morgan-Vilet Wve	FDA UDI	Class I	Active
Blake Kuwahara	BK1004-Cdr Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Bigr Blore-SltHrn	FDA UDI	Class I	Active
Blake Kuwahara	Albers-Grey Fade-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Maston-Tkyo Tort-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Frey-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Buff-Crystal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Ellwood-Navy	FDA UDI	Class I	Active
Blake Kuwahara	Bardi-Lake	FDA UDI	Class I	Active
Blake Kuwahara	BK1006-Antq Brwn	FDA UDI	Class I	Active
Blake Kuwahara	BK1007-Smoke	FDA UDI	Class I	Active
Blake Kuwahara	Cody-Fog	FDA UDI	Class I	Active
Blake Kuwahara	BK1017-Antiq Brn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1004-Blk Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Nelson-Grey Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Bowman-Snow-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Blore-Amber Horn	FDA UDI	Class I	Active
Blake Kuwahara	Gaudi-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1010-Cloud-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1018-Red-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Wells-Hunter-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Findley-Crimson	FDA UDI	Class I	Active
Blake Kuwahara	Lifesaver-Berry	FDA UDI	Class I	Active

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