FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Luminopia
K Number: K243819
·
Decision Apr 9, 2025
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
4
Review Days
118
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Luminopia
- K Number
- K243819
- 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
- December 12, 2024
- Decision Date
- April 9, 2025
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QQU), ordered by most recent decision date.
Luminopia
FDA 510(k)
FDA Class 2
·Ophthalmic
Luminopia One
FDA 510(k)
FDA Class 2
·Ophthalmic
CureSight-CS100
FDA 510(k)
FDA Class 2
·Ophthalmic
Luminopia One
FDA 510(k)
FDA Class 2
·Ophthalmic