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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 18 of 301
DeviceModel / ReferenceRegistriesClassStatus
Original Penguin SINCYG52
FDA UDI
Class IActive
Gallery PRSNBR53
FDA UDI
Class IActive
Vera Wang V317WI51
FDA UDI
Class IActive
Vera Wang V283BK49
FDA UDI
Class IActive
Lilly Pulitzer KIMMNV47
FDA UDI
Class IActive
Timex T501ME53
FDA UDI
Class IActive
Original Penguin FLDOBK53
FDA UDI
Class IActive
Original Penguin CDEABK54
FDA UDI
Class IActive
Vera Wang INGABK51
FDA UDI
Class IActive
Kensie ELGTCM51
FDA UDI
Class IActive
Vera Wang V562VI51
FDA UDI
Class IActive
Timex L051BK59
FDA UDI
Class IActive
Lilly Pulitzer ROXYPK47
FDA UDI
Class IActive
Vera Wang AURASI40
FDA UDI
Class IActive
Jhane Barnes PERMGM59
FDA UDI
Class IActive
Kensie IRDSFO52
FDA UDI
Class IActive
Lilly Pulitzer BDFDTO51
FDA UDI
Class IActive
Jhane Barnes SPHRGM49
FDA UDI
Class IActive
Timex TMX BLKRNV50
FDA UDI
Class IActive
Jhane Barnes FUNCBK50
FDA UDI
Class IActive
Paradigm 1902GM52
FDA UDI
Class IActive
Vera Wang V533MT51
FDA UDI
Class IActive
Zac Posen ZMRYBK50
FDA UDI
Class IActive
Kensie ADMRPU46
FDA UDI
Class IActive
Vera Wang V299AY54
FDA UDI
Class IActive
Vera Wang V062BU52
FDA UDI
Class IActive
Vera Wang V36 TO50
FDA UDI
Class IActive
Timex TMX 106XBL47
FDA UDI
Class IActive
Timex TMX HVYHBK52
FDA UDI
Class IActive
Timex 514PGM56
FDA UDI
Class IActive
Lilly Pulitzer LNTASK51
FDA UDI
Class IActive
Lilly Pulitzer STRBWH52
FDA UDI
Class IActive
Paradigm 2007SK51
FDA UDI
Class IActive
Timex TMX GOALBK47
FDA UDI
Class IActive
Gallery MACKBD49
FDA UDI
Class IActive
Timex 246PBK56
FDA UDI
Class IActive
Zac Posen ZJAYTO55
FDA UDI
Class IActive
Vera Wang VA26DN55
FDA UDI
Class IActive
Vera Wang PADMBK56
FDA UDI
Class IActive
Kensie FORRCE52
FDA UDI
Class IActive
Kensie HRMYPK51
FDA UDI
Class IActive
Lilly Pulitzer RSMRBL49
FDA UDI
Class IActive
Lilly Pulitzer MCCOGM48
FDA UDI
Class IActive
Vera Wang V074TA53
FDA UDI
Class IActive
Jhane Barnes QUANBR52
FDA UDI
Class IActive
Vera Wang V388TE51
FDA UDI
Class IActive
Vera Wang LORLBK52
FDA UDI
Class IActive
Vera Wang PENURO54
FDA UDI
Class IActive
Timex 729AYG55
FDA UDI
Class IActive
Zac Posen ZFREBR55
FDA UDI
Class IActive

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