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Sign in to claim this brandKenmark 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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- EUDAMED SRN
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Catalogue (15014)
Page 2 of 301| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vera Wang | V045IR48 | FDA UDI | Class I | Active |
| Vera Wang | MRKOBY46 | FDA UDI | Class I | Active |
| Vera Wang | PHNAAD50 | FDA UDI | Class I | Active |
| Vera Wang | V912TO52 | FDA UDI | Class I | Active |
| Lilly Pulitzer | BLEYSK50 | FDA UDI | Class I | Active |
| Original Penguin | DRAKBK52 | FDA UDI | Class I | Active |
| Timex | 308PBK55 | FDA UDI | Class I | Active |
| Gallery | MADXBK54 | FDA UDI | Class I | Active |
| Original Penguin | MTRMGM56 | FDA UDI | Class I | Active |
| Timex TMX | STRGBL50 | FDA UDI | Class I | Active |
| Kensie | PAINTE45 | FDA UDI | Class I | Active |
| Timex | X031NV48 | FDA UDI | Class I | Active |
| Timex TMX | MTHNNV53 | FDA UDI | Class I | Active |
| Vera Wang | EDN TO54 | FDA UDI | Class I | Active |
| Fundamentals | F004TO49 | FDA UDI | Class I | Active |
| Lilly Pulitzer | ARDLTO50 | FDA UDI | Class I | Active |
| Timex TMX | HATTBK49 | FDA UDI | Class I | Active |
| Kensie | BRVEGN49 | FDA UDI | Class I | Active |
| Original Penguin | STANBK53 | FDA UDI | Class I | Active |
| Zac Posen | ZBRAWT53 | FDA UDI | Class I | Active |
| Dana Buchman | PRMRCY54 | FDA UDI | Class I | Active |
| Vera Wang | VA49PK54 | FDA UDI | Class I | Active |
| Vera Wang | V376HN51 | FDA UDI | Class I | Active |
| Dana Buchman | PAMEES53 | FDA UDI | Class I | Active |
| Gallery | FINNYE48 | FDA UDI | Class I | Active |
| Republica | ALBNSL56 | FDA UDI | Class I | Active |
| Original Penguin | MNGAGR47 | FDA UDI | Class I | Active |
| Original Penguin | MTRMWH56 | FDA UDI | Class I | Active |
| Vera Wang | CMLLSC57 | FDA UDI | Class I | Active |
| Vera Wang | DALLRO54 | FDA UDI | Class I | Active |
| Vera Wang | V359TO53 | FDA UDI | Class I | Active |
| Zac Posen | ZODIBK55 | FDA UDI | Class I | Active |
| Dana Buchman | FARLBK52 | FDA UDI | Class I | Active |
| Timex | L069GM56 | FDA UDI | Class I | Active |
| Vera Wang | DNDRCY51 | FDA UDI | Class I | Active |
| Zac Posen | ZMDEFA54 | FDA UDI | Class I | Active |
| Gallery | BRITPK41 | FDA UDI | Class I | Active |
| Original Penguin | HUBEYG50 | FDA UDI | Class I | Active |
| Kensie | WHIMTO52 | FDA UDI | Class I | Active |
| Vera Wang | V388SC53 | FDA UDI | Class I | Active |
| Comfort Flex | NORMBR50 | FDA UDI | Class I | Active |
| Gallery | G502BR48 | FDA UDI | Class I | Active |
| Zac Posen | ZJNEGR54 | FDA UDI | Class I | Active |
| Zac Posen | ZLAWNV55 | FDA UDI | Class I | Active |
| Comfort Flex | CSSINV52 | FDA UDI | Class I | Active |
| Kensie | EDG BK53 | FDA UDI | Class I | Active |
| Vera Wang | V097BR49 | FDA UDI | Class I | Active |
| Vera Wang | DVTAAY50 | FDA UDI | Class I | Active |
| Kensie | ARTIMG49 | FDA UDI | Class I | Active |
| Fundamentals | F005DM48 | FDA UDI | Class I | Active |
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