510(k) K243819
- Device
- Luminopia
- Applicant
- Luminopia, Inc.
- 510(k) number
- K243819
- Product code
- QQU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-09
- Date received
- 2024-12-12
- Regulation
- 886.5500
- Classification name
- Digital Therapy Device For Amblyopia
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Scott Xiao
- Address
- 955 Massachusetts Ave. #335 Cambridge MA US 02139 02139
FDA Registration Numbers#
- 3023855046
- 3015168859