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Sign in to claim this brandInspecs U.S.A., L.C.
US
Last updated May 23, 2026
What Inspecs U.S.A., L.C. makes
Inspecs U.S.A., L.C. manufactures spectacle frames, including designs such as O’NEILL, BOTANIQ, FINTECH, LOCO SKAILZ, CATERPILLAR, and REEL LEGENDS. These products are intended for use in corrective eyewear and are marketed under distinct branding to cater to various aesthetic preferences.
The company’s products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory requirements for spectacle frames.
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 Inspecs U.S.A., L.C. manufacture?
Inspecs U.S.A., L.C. specializes in spectacle frames, which are designed for use in corrective eyewear. These devices are branded under names like O’NEILL, BOTANIQ, FINTECH, LOCO SKAILZ, CATERPILLAR, and REEL LEGENDS, catering to different style preferences while serving the primary function of supporting eyeglass lenses.
Where is Inspecs U.S.A., L.C. based, and how does that affect its devices?
Inspecs U.S.A., L.C. is based in the United States, where it operates under the regulatory framework governing medical devices in that country. Since spectacle frames fall under FDA Class I classification, the company must comply with U.S. regulatory standards, including listing its devices in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and transparency.
Which regulatory registries or databases list Inspecs U.S.A., L.C.’s devices?
Inspecs U.S.A., L.C.’s spectacle frames are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring compliance with regulatory requirements and facilitating market surveillance. The inclusion in this database reflects the company’s adherence to FDA guidelines for Class I devices.
How are Inspecs U.S.A., L.C.’s spectacle frames classified by regulatory authorities?
Inspecs U.S.A., L.C.’s spectacle frames are classified as FDA Class I medical devices. This classification is determined by the U.S. Food and Drug Administration based on the risk associated with the device. Class I devices are generally considered low-risk and typically require only general controls to ensure safety and effectiveness, though they must still meet regulatory listing requirements like UDI registration.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 845937478
Catalogue (179)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O'neill | ONS-ENSENADA2.0-104P | FDA UDI | Class I | Active |
| Botaniq | BIS-7019-102 | FDA UDI | Class I | Active |
| Botaniq | BIS-7007-113 | FDA UDI | Class I | Active |
| O'neill | ONS-PAIPO2.0-104P | FDA UDI | Class I | Active |
| Botaniq | BIS-7010-104 | FDA UDI | Class I | Active |
| Botaniq | BIS-7017-105 | FDA UDI | Class I | Active |
| Fintech | FTS-GREAT WHITE-104P | FDA UDI | Class I | Active |
| Botaniq | BIS-7020-105 | FDA UDI | Class I | Active |
| Loco Skailz | LSS-KINGSTON-108P | FDA UDI | Class I | Active |
| Caterpillar | CTS-BLINDING-113P | FDA UDI | Class I | Active |
| Caterpillar | CTS-8016-108P | FDA UDI | Class I | Active |
| Reel Legends | BRS-MONTAUK-127P | FDA UDI | Class I | Active |
| Caterpillar | CTS-HOOK-108 | FDA UDI | Class I | Active |
| Caterpillar | CTS-PURLIN-102P | FDA UDI | Class I | Active |
| Radley | RDS-TULIP-161 | FDA UDI | Class I | Active |
| Botaniq | BIS-7007-104 | FDA UDI | Class I | Active |
| O'neill | ONS-TREVOSE-106P-ST | FDA UDI | Class I | Active |
| Botaniq | BIS-7006-197 | FDA UDI | Class I | Active |
| Superdry | SDS-STUDIOSADIE-272 | FDA UDI | Class I | Active |
| Botaniq | BIS-7017-102 | FDA UDI | Class I | Active |
| Radley | RDS-RAYANNA-162 | FDA UDI | Class I | Active |
| Superdry | SDS-STUDIOSADIE-002 | FDA UDI | Class I | Active |
| Carlos Santana | STS-NOBLE-106P | FDA UDI | Class I | Active |
| Botaniq | BIS-7015-104 | FDA UDI | Class I | Active |
| Caterpillar | CTS-GRADER-102P | FDA UDI | Class I | Active |
| Carlos Santana | STS-VUKU-102P | FDA UDI | Class I | Active |
| Botaniq | BIS-7015-105 | FDA UDI | Class I | Active |
| Carlos Santana | CSS-BRIANNE-162P | FDA UDI | Class I | Active |
| Botaniq | BIS-7018-127 | FDA UDI | Class I | Active |
| Caterpillar | CTS-RIDGE-102P | FDA UDI | Class I | Active |
| Botaniq | BIS-7010-105 | FDA UDI | Class I | Active |
| Caterpillar | CTS-8023-002P | FDA UDI | Class I | Active |
| O'neill | ONS-ENSENADA2.0-106P | FDA UDI | Class I | Active |
| Fintech | FTS-TOPWATER-004P | FDA UDI | Class I | Active |
| Caterpillar | CTS-8016-113P | FDA UDI | Class I | Active |
| Carlos Santana | CSS-BRIANNE-107P | FDA UDI | Class I | Active |
| Fintech | FTS-THRESHER-104P | FDA UDI | Class I | Active |
| Fintech | FTS-BULL-198P | FDA UDI | Class I | Active |
| Botaniq | BIS-7001-125 | FDA UDI | Class I | Active |
| Botaniq | BIS-7012-150 | FDA UDI | Class I | Active |
| Botaniq | BIS-7002-102 | FDA UDI | Class I | Active |
| Botaniq | BIS-7014-152 | FDA UDI | Class I | Active |
| Botaniq | BIS-7020-102 | FDA UDI | Class I | Active |
| Radley | RDS-RAYANNA-104 | FDA UDI | Class I | Active |
| Carlos Santana | CSS-BRIANNE-104P | FDA UDI | Class I | Active |
| Caterpillar | CTS-RIGGER-102P | FDA UDI | Class I | Active |
| Carlos Santana | CSS-AMARA-160P | FDA UDI | Class I | Active |
| Superdry | SDS-STUDIOSCREW-001 | FDA UDI | Class I | Active |
| Botaniq | BIS-7006-153 | FDA UDI | Class I | Active |
| Fintech | FTS-GREAT WHITE-204P | FDA UDI | Class I | Active |
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