510(k) K221659
- Device
- Luminopia One
- Applicant
- Luminopia, Inc.
- 510(k) number
- K221659
- Product code
- QQU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-04
- Date received
- 2022-06-08
- 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
- No
Applicant Contact#
- Contact
- Scott Xiao
- Address
- 955 Massachusetts Ave. #335 Cambridge MA US 02139 02139
FDA Registration Numbers#
- 3023855046
- 3015168859
Source Documents#
Other 510(k) Records For Product Code QQU #
Legacy Summary#
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FDA Review#
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