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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 14 of 301
DeviceModel / ReferenceRegistriesClassStatus
Timex TMX PINSBK54
FDA UDI
Class IActive
Vera Wang AGLABK53
FDA UDI
Class IActive
Lilly Pulitzer CPLNTO48
FDA UDI
Class IActive
Lilly Pulitzer CHRISB50
FDA UDI
Class IActive
Republica BARLPU52
FDA UDI
Class IActive
Vera Wang ALLUBU52
FDA UDI
Class IActive
Vera Wang DLCTYG54
FDA UDI
Class IActive
Vera Wang V120TA52
FDA UDI
Class IActive
Lilly Pulitzer BRIDBR52
FDA UDI
Class IActive
Timex 330PBK54
FDA UDI
Class IActive
Gallery DUBLBR51
FDA UDI
Class IActive
Lilly Pulitzer WRIGNV48
FDA UDI
Class IActive
Kensie FLSHBK53
FDA UDI
Class IActive
Gallery EVITBR48
FDA UDI
Class IActive
Kensie MOTNCL51
FDA UDI
Class IActive
Timex 431PBK55
FDA UDI
Class IActive
Lilly Pulitzer POSEWH51
FDA UDI
Class IActive
Timex TMX PIN OL49
FDA UDI
Class IActive
Kensie FEATBK52
FDA UDI
Class IActive
Zac Posen ZSELML49
FDA UDI
Class IActive
Vera Wang SRASBK57
FDA UDI
Class IActive
Kensie JENSBL48
FDA UDI
Class IActive
Dana Buchman EUGEBK52
FDA UDI
Class IActive
Zac Posen ZJACBK54
FDA UDI
Class IActive
Lilly Pulitzer LINNGP52
FDA UDI
Class IActive
Vera Wang V261SU54
FDA UDI
Class IActive
Comfort Flex EARLBR55
FDA UDI
Class IActive
Kensie DISCMA52
FDA UDI
Class IActive
Dana Buchman PAISIR54
FDA UDI
Class IActive
Original Penguin TGENBK47
FDA UDI
Class IActive
Lilly Pulitzer CHELRD45
FDA UDI
Class IActive
Lilly Pulitzer NITATO54
FDA UDI
Class IActive
Kensie ELXRNV54
FDA UDI
Class IActive
Vera Wang GEM PL50
FDA UDI
Class IActive
Kensie EDGYBK53
FDA UDI
Class IActive
Gallery SCARRO54
FDA UDI
Class IActive
Zac Posen ZTECOL53
FDA UDI
Class IActive
Jhane Barnes SRFCGM54
FDA UDI
Class IActive
Gallery G514LB41
FDA UDI
Class IActive
Gallery LLOYLB55
FDA UDI
Class IActive
Lilly Pulitzer BRLWPU52
FDA UDI
Class IActive
Timex TMX TIE NV48
FDA UDI
Class IActive
Lilly Pulitzer STRBNV52
FDA UDI
Class IActive
Lilly Pulitzer LNDLBL52
FDA UDI
Class IActive
Vera Wang SAGABR54
FDA UDI
Class IActive
Jhane Barnes CUSPGM57
FDA UDI
Class IActive
Timex TMX POSSBK53
FDA UDI
Class IActive
Paradigm 2108SL52
FDA UDI
Class IActive
Vera Wang V542DN52
FDA UDI
Class IActive
Original Penguin DNLYGR52
FDA UDI
Class IActive

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