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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 25 of 301
DeviceModel / ReferenceRegistriesClassStatus
Vera Wang MRALBX52
FDA UDI
Class IActive
Vera Wang V389HN54
FDA UDI
Class IActive
Zac Posen ZKIADN49
FDA UDI
Class IActive
Vera Wang TLYANO55
FDA UDI
Class IActive
Lilly Pulitzer CLHNBU50
FDA UDI
Class IActive
Kensie UPTOBK52
FDA UDI
Class IActive
Original Penguin BTDRBK53
FDA UDI
Class IActive
Original Penguin TRBLBL54
FDA UDI
Class IActive
Vera Wang VAS1BK56
FDA UDI
Class IActive
Zac Posen ZCHATO54
FDA UDI
Class IActive
Kensie DRNGPK48
FDA UDI
Class IActive
Paradigm 1938TO55
FDA UDI
Class IActive
Lilly Pulitzer STEPPU48
FDA UDI
Class IActive
Vera Wang V545MO53
FDA UDI
Class IActive
Vera Wang GVIIBL53
FDA UDI
Class IActive
Original Penguin BRYOGM51
FDA UDI
Class IActive
Lilly Pulitzer SYDYNV49
FDA UDI
Class IActive
Vera Wang V373BR52
FDA UDI
Class IActive
Kensie MODYAQ47
FDA UDI
Class IActive
Vera Wang TATILE54
FDA UDI
Class IActive
Kensie GRVYTO49
FDA UDI
Class IActive
Vera Wang V002GR51
FDA UDI
Class IActive
Kensie SQUDBK46
FDA UDI
Class IActive
Vera Wang PLUSBK53
FDA UDI
Class IActive
Vera Wang V469HE52
FDA UDI
Class IActive
Lilly Pulitzer KLMIOC47
FDA UDI
Class IActive
Original Penguin RTHRGM49
FDA UDI
Class IActive
Kensie GMETTO48
FDA UDI
Class IActive
Gallery KENNBK56
FDA UDI
Class IActive
Vera Wang V047BK52
FDA UDI
Class IActive
Timex 752PNV51
FDA UDI
Class IActive
Jhane Barnes MLTIGM57
FDA UDI
Class IActive
Timex L053NV57
FDA UDI
Class IActive
Vera Wang EDN NH54
FDA UDI
Class IActive
Vera Wang VCTOBR51
FDA UDI
Class IActive
Vera Wang HRTAAY53
FDA UDI
Class IActive
Vera Wang V283PR49
FDA UDI
Class IActive
Zac Posen ZWARSF50
FDA UDI
Class IActive
Comfort Flex DRINBR55
FDA UDI
Class IActive
Lilly Pulitzer REILBK48
FDA UDI
Class IActive
Lilly Pulitzer CRLTTO46
FDA UDI
Class IActive
Lilly Pulitzer SAWYNV48
FDA UDI
Class IActive
Vera Wang INGAMB51
FDA UDI
Class IActive
Dana Buchman DPHIMO53
FDA UDI
Class IActive
Timex X042SA54
FDA UDI
Class IActive
Gallery ANTODA48
FDA UDI
Class IActive
Lilly Pulitzer CRCEDT00
FDA UDI
Class IActive
Vera Wang VA44TO53
FDA UDI
Class IActive
Vera Wang KRNABK54
FDA UDI
Class IActive
Vera Wang ZARINH55
FDA UDI
Class IActive

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