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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 4 of 301
DeviceModel / ReferenceRegistriesClassStatus
Dana Buchman SLMEBK52
FDA UDI
Class IActive
Vera Wang VA34CI54
FDA UDI
Class IActive
Zac Posen ZREDTO54
FDA UDI
Class IActive
Jhane Barnes PROCTO56
FDA UDI
Class IActive
Dana Buchman MERIBK48
FDA UDI
Class IActive
Timex TMX RISENV53
FDA UDI
Class IActive
Original Penguin JSTNYG49
FDA UDI
Class IActive
Lilly Pulitzer SNTRTO53
FDA UDI
Class IActive
Lilly Pulitzer IMOGNV48
FDA UDI
Class IActive
Kensie ELMTOL51
FDA UDI
Class IActive
Kensie CHMPIN53
FDA UDI
Class IActive
Vera Wang VA20BU56
FDA UDI
Class IActive
Timex 223POL54
FDA UDI
Class IActive
Timex TMX RAKENV47
FDA UDI
Class IActive
Dana Buchman MAGLBU54
FDA UDI
Class IActive
Zac Posen ZDSMTO48
FDA UDI
Class IActive
Paradigm 2107AZ51
FDA UDI
Class IActive
Lilly Pulitzer WAYLPK48
FDA UDI
Class IActive
Dana Buchman JNTEGR52
FDA UDI
Class IActive
Vera Wang NEDABK50
FDA UDI
Class IActive
Original Penguin SMONAG48
FDA UDI
Class IActive
Vera Wang V285TE54
FDA UDI
Class IActive
Lilly Pulitzer TEEKPL51
FDA UDI
Class IActive
Dana Buchman LILEEB54
FDA UDI
Class IActive
Vera Wang GAR2BK50
FDA UDI
Class IActive
Original Penguin GONDTO57
FDA UDI
Class IActive
Original Penguin HUJRNV47
FDA UDI
Class IActive
Timex TMX OFFSBR44
FDA UDI
Class IActive
Lilly Pulitzer REAGHV48
FDA UDI
Class IActive
Zac Posen ZLELBK48
FDA UDI
Class IActive
Vera Wang V164ES50
FDA UDI
Class IActive
Original Penguin WEBLRP54
FDA UDI
Class IActive
Vera Wang V447OS54
FDA UDI
Class IActive
Paradigm 2008FO50
FDA UDI
Class IActive
Lilly Pulitzer ROXYBL45
FDA UDI
Class IActive
Vera Wang CHERCH53
FDA UDI
Class IActive
Lilly Pulitzer DAIQGS15
FDA UDI
Class IActive
Gallery G535BR49
FDA UDI
Class IActive
Gallery JAMIBK44
FDA UDI
Class IActive
Vera Wang V446TO55
FDA UDI
Class IActive
Jhane Barnes TRDLBK55
FDA UDI
Class IActive
Lilly Pulitzer LANETO51
FDA UDI
Class IActive
Dana Buchman CLLACB53
FDA UDI
Class IActive
Lilly Pulitzer MNTROC55
FDA UDI
Class IActive
Vera Wang V045IR50
FDA UDI
Class IActive
Gallery TORIDA48
FDA UDI
Class IActive
Jhane Barnes ALTEST57
FDA UDI
Class IActive
Jhane Barnes ANLGBK57
FDA UDI
Class IActive
Fundamentals F007WI50
FDA UDI
Class IActive
Timex 308PBR55
FDA UDI
Class IActive

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