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Sign in to claim this brandWhat Read On Inc. makes
Read On Inc. manufactures prescription spectacles designed to correct refractive errors, including single-vision and progressive lenses. These devices are intended for use in optical correction for vision impairment, catering to both general and specialized visual needs.
The company’s products fall under Class I medical devices, as classified by the FDA, and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory requirements for optical devices in that jurisdiction.
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 Read On Inc. manufacture?
Read On Inc. specializes in prescription spectacles, including single-vision and progressive lenses. These devices are designed to correct refractive errors and address vision impairment, providing optical correction for patients with varying visual needs.
Where is Read On Inc. based, and how does this affect its devices?
Read On Inc. is based in the United States. Since its devices are manufactured domestically, they must comply with U.S. regulatory standards, including classification under the FDA’s framework. This ensures alignment with local requirements for optical correction devices.
How are Read On Inc.’s devices classified by regulatory authorities?
Read On Inc.’s prescription spectacles are classified as Class I medical devices by the FDA. This classification applies to low-risk devices where general controls are sufficient to ensure safety and effectiveness, such as optical correction lenses.
Are Read On Inc.’s devices listed in any regulatory registries?
Yes, Read On Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardized identifier, ensuring transparency and traceability for prescription spectacles.
Why are Read On Inc.’s devices categorized as Class I?
The FDA categorizes prescription spectacles as Class I because they pose minimal risk to patients. These devices are intended for straightforward optical correction without invasive procedures or significant health risks, so general regulatory controls are deemed adequate.
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
- 118891606
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| read on | 7640288790823 | FDA UDI | Class I | Active |
| read on | 7640288790724 | FDA UDI | Class I | Active |
| read on | 7640288790793 | FDA UDI | Class I | Active |
| read on | 7640288790762 | FDA UDI | Class I | Active |
| read on | 7640288790601 | FDA UDI | Class I | Active |
| read on | 7640288790649 | FDA UDI | Class I | Active |
| read on | 7640288790632 | FDA UDI | Class I | Active |
| read on | 7640288790731 | FDA UDI | Class I | Active |
| read on | 7640288790656 | FDA UDI | Class I | Active |
| read on | 7640288790595 | FDA UDI | Class I | Active |
| read on | 7640288790786 | FDA UDI | Class I | Active |
| read on | 7640288790816 | FDA UDI | Class I | Active |
| read on | 7640288790670 | FDA UDI | Class I | Active |
| read on | 7640288790779 | FDA UDI | Class I | Active |
| read on | 7640288790618 | FDA UDI | Class I | Active |
| read on | 7640288790717 | FDA UDI | Class I | Active |
| read on | 7640288790694 | FDA UDI | Class I | Active |
| read on | 7640288790700 | FDA UDI | Class I | Active |
| read on | 7640288790663 | FDA UDI | Class I | Active |
| read on | 7640288790687 | FDA UDI | Class I | Active |
| read on | 7640288790809 | FDA UDI | Class I | Active |
| read on | 7640288790748 | FDA UDI | Class I | Active |
| read on | 7640288790755 | FDA UDI | Class I | Active |
| read on | 7640288790625 | FDA UDI | Class I | Active |
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