510(k) DEN210005
- Device
- Luminopia One
- Applicant
- Luminopia, Inc.
- 510(k) number
- DEN210005
- Product code
- QQU
- Decision
- Unknown (DENG)
- Decision date
- 2021-10-20
- Date received
- 2021-03-01
- Regulation
- 886.5500
- Classification name
- Digital Therapy Device For Amblyopia
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Scott Xiao
- Address
- 955 Massachusetts Ave. #335 Cambridge MA US 02139 02139
FDA Registration Numbers#
- 3023855046
- 3015168859
Source Documents#
510(k) summary PDF not indicated by FDA