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	Maston-Navy Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Delano-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Brown Hrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Buff-Vapor-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Paley-Hickory	FDA UDI	Class I	Active
Blake Kuwahara	Paley-Taupe	FDA UDI	Class I	Active
Blake Kuwahara	BK1014-Brsh Mdnt	FDA UDI	Class I	Active
Blake Kuwahara	Landis-Vlt Mrbl-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1007-Smoke-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Owings-Charcoal	FDA UDI	Class I	Active
Blake Kuwahara	BK1004-Gry Horn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Ellwood-Tortoise	FDA UDI	Class I	Active
Blake Kuwahara	Buff-Cypress	FDA UDI	Class I	Active
Blake Kuwahara	Hall-Amber Horn	FDA UDI	Class I	Active
Blake Kuwahara	BK1016-Violet Fd-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Maston-Ambr Tort-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Turnbull-Hickory-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Findley-Wht Strp-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Albers-Chstnt Fd-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Haussmann-GryHrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1007-Charcoal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Chambers-Pride-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Cody-Ink	FDA UDI	Class I	Active
Blake Kuwahara	Cody-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Blore-Midnight-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Wells-Hunter	FDA UDI	Class I	Active
Blake Kuwahara	Fletcher-Blu Hrn-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Landis-Sea Foam-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1012-Mist-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1015-Eggplant-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1007-Russet	FDA UDI	Class I	Active
Blake Kuwahara	Findley-Blk Web	FDA UDI	Class I	Active
Blake Kuwahara	Portman-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Reed-Brown Horn	FDA UDI	Class I	Active
Blake Kuwahara	Chambers-Oyster	FDA UDI	Class I	Active
Blake Kuwahara	Chambers-Teal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Merrill-Grass	FDA UDI	Class I	Active
Blake Kuwahara	Bowman-Snow	FDA UDI	Class I	Active
Blake Kuwahara	Bardi-Moss	FDA UDI	Class I	Active
Blake Kuwahara	Cobb-Grey Horn	FDA UDI	Class I	Active
Blake Kuwahara	Ellwood-Midnight	FDA UDI	Class I	Active
Blake Kuwahara	Merrill-Gry Strw-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1009-Flint-Sun	FDA UDI	Class I	Active
Blake Kuwahara	BK1004-Cdr Horn	FDA UDI	Class I	Active
Blake Kuwahara	Haussmann-Crystl-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Stanton-Gunmetal-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Landis-Sea Foam	FDA UDI	Class I	Active
Blake Kuwahara	Findley-Amethyst-Sun	FDA UDI	Class I	Active
Blake Kuwahara	Landis-Vlt Mrbl	FDA UDI	Class I	Active
Blake Kuwahara	BK1016-Grey Fade-Sun	FDA UDI	Class I	Active

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