FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STARband, STARlight, St. Louis Band
K Number: K180109
·
Decision Mar 1, 2018
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
22
Applicant Total
21
Review Days
44
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Basic Information
- Device Name
- STARband, STARlight, St. Louis Band
- K Number
- K180109
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5970
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthomerica Products, Inc.
- Date Received
- January 16, 2018
- Decision Date
- March 1, 2018
- Product Code
- OAN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAN | Orthosis, Cranial, Laser Scan | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAN), ordered by most recent decision date.
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STARband, STARlight, St. Louis Band
FDA 510(k)
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FDA 510(k)
FDA Class 2
·Neurology
STARband, STARlight
FDA 510(k)
FDA Class 2
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Other Clearances by Orthomerica Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240466 | STARband 3D | Mar 15, 2024 | Substantially Equivalent |
| K223238 | STARband 3D | Apr 20, 2023 | Substantially Equivalent |
| K211376 | STARband | Aug 17, 2021 | Substantially Equivalent |
| K203098 | STARband, STARlight, St. Louis Band | Apr 27, 2021 | Substantially Equivalent |
| K161138 | St. Louis Band | Jul 20, 2016 | Substantially Equivalent |
| K151979 | STARband, STARlight | Sep 18, 2015 | Substantially Equivalent |
| K151147 | STARband, STARlight | Jul 1, 2015 | Substantially Equivalent |
| K142141 | STARBAND, STARLIGHT | Apr 23, 2015 | Substantially Equivalent |
| K141842 | STARBAND, STARLIGHT | Oct 6, 2014 | Substantially Equivalent |
| K140353 | STARBAND AND STARLIGHT | Jun 6, 2014 | Substantially Equivalent |