Identifiers
- 510(k) Number
- K151147 FDA 510(k)
- FDA Product Code
- OAN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5970 FDA 510(k)
- Regulation Number
- 882.5970 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STARband, also known as the Starlight, is a reliable and accurate laser scan orthosis designed for neurology professionals in Florida. This device provides precise measurements and guidance to help patients achieve optimal outcomes.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151147 | Class II | Active |
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Manufacturer
- Manufacturer
- Orthomerica Products, Inc.
Sources (1)
- FDA 510(k) K151147 24 fields · synced Jun 28, 2026