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Kenmark Optical Co., Inc.

US

Last updated May 23, 2026

What Kenmark Optical Co., Inc. makes

Kenmark Optical Co., Inc. manufactures prescription spectacles, including branded frames such as Lilly Pulitzer, Vera Wang, Timex, Kensie, and Dana Buchman, as well as tinted non-prescription spectacles like the Original Penguin. Their product line includes both functional eyewear for vision correction and fashion-oriented sunglasses and non-prescription lenses.

All devices produced by Kenmark Optical Co., Inc. fall under FDA Class I regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kenmark Optical Co., Inc. manufacture?

Kenmark Optical Co., Inc. specializes in two primary categories of eyewear: prescription spectacles for vision correction and tinted non-prescription spectacles, including sunglasses. Their product line includes branded frames like Lilly Pulitzer, Vera Wang, Timex, Kensie, and Dana Buchman, as well as non-prescription designs such as the Original Penguin. These devices are intended for both functional and fashion-oriented use.

Where is Kenmark Optical Co., Inc. based, and what does that mean for their regulatory oversight?

Kenmark Optical Co., Inc. is based in the United States, which means their devices are subject to FDA regulations. Since their products fall under Class I classification, they are generally considered low-risk and require listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and compliance with U.S. medical device regulations.

Which regulatory registries list Kenmark Optical Co., Inc.’s devices?

Kenmark Optical Co., Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product is identifiable and traceable, which is a requirement for Class I devices under U.S. medical device regulations. The UDI system helps track devices throughout their lifecycle, including manufacturing, distribution, and use.

How are Kenmark Optical Co., Inc.’s devices classified by the FDA, and why does this matter?

Kenmark Optical Co., Inc.’s devices are classified as FDA Class I, which means they are considered low-risk and pose minimal potential harm to users. This classification simplifies regulatory requirements, such as mandatory listing in the FDA’s UDI database, but does not exempt the company from ensuring compliance with manufacturing and labeling standards. Class I devices are typically exempt from premarket approval but still require adherence to general controls.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (15014)

Page 10 of 301
DeviceModel / ReferenceRegistriesClassStatus
Timex 918ABK54
FDA UDI
Class IActive
Dana Buchman BTRZWI52
FDA UDI
Class IActive
Jhane Barnes GRPTST53
FDA UDI
Class IActive
Timex TMX SLINBR50
FDA UDI
Class IActive
Kensie TRIBTO53
FDA UDI
Class IActive
Lilly Pulitzer DLLATO52
FDA UDI
Class IActive
Timex STAYEG52
FDA UDI
Class IActive
Lilly Pulitzer CAROPK45
FDA UDI
Class IActive
Zac Posen ZCARTO54
FDA UDI
Class IActive
Vera Wang V345LI52
FDA UDI
Class IActive
Lilly Pulitzer BCHYPT20
FDA UDI
Class IActive
Kensie PEPLBU51
FDA UDI
Class IActive
Vera Wang V342ME52
FDA UDI
Class IActive
Lilly Pulitzer KATYTO49
FDA UDI
Class IActive
Vera Wang V007DM50
FDA UDI
Class IActive
Vera Wang STLLSM51
FDA UDI
Class IActive
Vera Wang V079BU53
FDA UDI
Class IActive
Vera Wang V352BK51
FDA UDI
Class IActive
Fundamentals F006WI50
FDA UDI
Class IActive
Dana Buchman MRIGBK54
FDA UDI
Class IActive
Kensie ROMCBK49
FDA UDI
Class IActive
Original Penguin DEMPTR49
FDA UDI
Class IActive
Vera Wang V278BK56
FDA UDI
Class IActive
Timex T305BR47
FDA UDI
Class IActive
Lilly Pulitzer HOLBAQ52
FDA UDI
Class IActive
Lilly Pulitzer FIA NV54
FDA UDI
Class IActive
Lilly Pulitzer EMIKBL51
FDA UDI
Class IActive
Vera Wang VE01BK53
FDA UDI
Class IActive
Vera Wang V031BU53
FDA UDI
Class IActive
Timex TMX PIKEGR48
FDA UDI
Class IActive
Destiny TIFFNV52
FDA UDI
Class IActive
Destiny LEXNBR53
FDA UDI
Class IActive
Timex T196BR52
FDA UDI
Class IActive
Vera Wang V165TZ48
FDA UDI
Class IActive
Timex TMX POSSNV51
FDA UDI
Class IActive
Paradigm 2105YC53
FDA UDI
Class IActive
Timex X039LI54
FDA UDI
Class IActive
Original Penguin HPR2MD51
FDA UDI
Class IActive
Vera Wang V567PI50
FDA UDI
Class IActive
Timex VENTNV51
FDA UDI
Class IActive
Jhane Barnes ANLGBK55
FDA UDI
Class IActive
Original Penguin TETERR51
FDA UDI
Class IActive
Lilly Pulitzer DAIQGA20
FDA UDI
Class IActive
Lilly Pulitzer MEG BK52
FDA UDI
Class IActive
Lilly Pulitzer FRCOPL49
FDA UDI
Class IActive
Lilly Pulitzer SADITO45
FDA UDI
Class IActive
Gemma Styles Sun Coll BASTCB52
FDA UDI
Class IActive
Zac Posen ZFARBK55
FDA UDI
Class IActive
Jhane Barnes RDX1BK50
FDA UDI
Class IActive
Timex TMX SLIDBR52
FDA UDI
Class IActive

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