FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Luminopia One
K Number: K221659
·
Decision Nov 4, 2022
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
4
Review Days
149
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Basic Information
- Device Name
- Luminopia One
- K Number
- K221659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5500
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Luminopia, Inc.
- Date Received
- June 8, 2022
- Decision Date
- November 4, 2022
- Product Code
- QQU
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| QQU | Digital Therapy Device For Amblyopia | FDA class 2 | Ophthalmic |
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