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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 28 of 301
DeviceModel / ReferenceRegistriesClassStatus
Kensie CHECBR47
FDA UDI
Class IActive
Jhane Barnes POSTST54
FDA UDI
Class IActive
Vera Wang V007TA50
FDA UDI
Class IActive
Vera Wang MIKIBH53
FDA UDI
Class IActive
Zac Posen ZHAYBR55
FDA UDI
Class IActive
Timex TMX SAFENV52
FDA UDI
Class IActive
Original Penguin DREXDS53
FDA UDI
Class IActive
Kensie GLAMCA50
FDA UDI
Class IActive
Original Penguin HUCKOL56
FDA UDI
Class IActive
Lilly Pulitzer TREENV48
FDA UDI
Class IActive
Vera Wang FNTNBU54
FDA UDI
Class IActive
Vera Wang V162MO52
FDA UDI
Class IActive
Lilly Pulitzer KELTNV53
FDA UDI
Class IActive
Lilly Pulitzer JNNEUT00
FDA UDI
Class IActive
Dana Buchman ROSEBK54
FDA UDI
Class IActive
Vera Wang V427WT56
FDA UDI
Class IActive
Lilly Pulitzer BREETH25
FDA UDI
Class IActive
Paradigm 2151AZ50
FDA UDI
Class IActive
Lilly Pulitzer HAMNTO52
FDA UDI
Class IActive
Lilly Pulitzer KINGTE49
FDA UDI
Class IActive
Original Penguin TRBLKP56
FDA UDI
Class IActive
Original Penguin ERL2RG59
FDA UDI
Class IActive
Lilly Pulitzer BECNTO51
FDA UDI
Class IActive
Timex TMX BLKRBK48
FDA UDI
Class IActive
Vera Wang LAGIBY52
FDA UDI
Class IActive
Dana Buchman LRELDR50
FDA UDI
Class IActive
Timex TMX PLNEBK50
FDA UDI
Class IActive
Timex TMX ADENBR49
FDA UDI
Class IActive
Original Penguin CLJRTO48
FDA UDI
Class IActive
Original Penguin MARVBK49
FDA UDI
Class IActive
Vera Wang V022SU50
FDA UDI
Class IActive
Zac Posen ZGIOBK49
FDA UDI
Class IActive
Timex 204PSL57
FDA UDI
Class IActive
Kensie ETHEAM50
FDA UDI
Class IActive
Original Penguin DOYLCR49
FDA UDI
Class IActive
Vera Wang V131BX52
FDA UDI
Class IActive
Lilly Pulitzer HLEETO56
FDA UDI
Class IActive
Vera Wang LELAEM53
FDA UDI
Class IActive
Dana Buchman HLGHBK51
FDA UDI
Class IActive
Gallery FEBEGN45
FDA UDI
Class IActive
Timex TMX BLITBK51
FDA UDI
Class IActive
Zac Posen ZSELGR49
FDA UDI
Class IActive
Vera Wang VA13BU52
FDA UDI
Class IActive
Jhane Barnes QUNTST56
FDA UDI
Class IActive
Jhane Barnes CSNTBK55
FDA UDI
Class IActive
Kensie KISSBL51
FDA UDI
Class IActive
Vera Wang ACACBK51
FDA UDI
Class IActive
Kensie FLTRTQ50
FDA UDI
Class IActive
Timex TMX OVTMGM53
FDA UDI
Class IActive
Timex X036BR57
FDA UDI
Class IActive

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