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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 26 of 301
DeviceModel / ReferenceRegistriesClassStatus
Jhane Barnes STRUGM52
FDA UDI
Class IActive
Fundamentals F023BR51
FDA UDI
Class IActive
Zac Posen ZHUMTO51
FDA UDI
Class IActive
Original Penguin HUCKTO56
FDA UDI
Class IActive
Timex 233PNV54
FDA UDI
Class IActive
Timex TMX NOLLNV47
FDA UDI
Class IActive
Vera Wang V238HA63
FDA UDI
Class IActive
Jhane Barnes CONVBR54
FDA UDI
Class IActive
Lilly Pulitzer STRBTE52
FDA UDI
Class IActive
Zac Posen ZKOUNV54
FDA UDI
Class IActive
Kensie MOTIJU51
FDA UDI
Class IActive
Timex TMX DUGOBK46
FDA UDI
Class IActive
Vera Wang V317AZ53
FDA UDI
Class IActive
Gallery FINNCR48
FDA UDI
Class IActive
Vera Wang V461BK53
FDA UDI
Class IActive
Gallery KENNTO52
FDA UDI
Class IActive
Original Penguin FLDONV53
FDA UDI
Class IActive
Destiny DELRBR53
FDA UDI
Class IActive
Vera Wang TAFFVI53
FDA UDI
Class IActive
Vera Wang LCIESU48
FDA UDI
Class IActive
Jhane Barnes AXIOST57
FDA UDI
Class IActive
Vera Wang AILESI56
FDA UDI
Class IActive
Vera Wang NYAHYG57
FDA UDI
Class IActive
Vera Wang VA21TO54
FDA UDI
Class IActive
Dana Buchman VLNEBX51
FDA UDI
Class IActive
Timex TMX SIDEGM47
FDA UDI
Class IActive
Gallery MRCOBR49
FDA UDI
Class IActive
Gallery SCARRO52
FDA UDI
Class IActive
Lilly Pulitzer ABYGTO54
FDA UDI
Class IActive
Original Penguin FALKBL55
FDA UDI
Class IActive
Original Penguin LNRDBK57
FDA UDI
Class IActive
Vera Wang V349BK51
FDA UDI
Class IActive
Lilly Pulitzer BRTITO53
FDA UDI
Class IActive
Lilly Pulitzer LYLARY50
FDA UDI
Class IActive
Vera Wang V318TO52
FDA UDI
Class IActive
Vera Wang V317WI53
FDA UDI
Class IActive
Vera Wang V327BR52
FDA UDI
Class IActive
Vera Wang AMINSU00
FDA UDI
Class IActive
Dana Buchman KTHLWI53
FDA UDI
Class IActive
Wolverine W044GM54
FDA UDI
Class IActive
Vera Wang AYANTO56
FDA UDI
Class IActive
Lilly Pulitzer AMLIBR47
FDA UDI
Class IActive
Lilly Pulitzer CASSBL54
FDA UDI
Class IActive
Vera Wang CAMACM52
FDA UDI
Class IActive
Comfort Flex JOBETO50
FDA UDI
Class IActive
Lilly Pulitzer OYSTBR20
FDA UDI
Class IActive
Vera Wang V578CA53
FDA UDI
Class IActive
Vera Wang SHO TO51
FDA UDI
Class IActive
Dana Buchman BEVEGM52
FDA UDI
Class IActive
Gallery PAULTN48
FDA UDI
Class IActive

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