510(k) K243729
- Device
- Prismira
- Applicant
- Lumos Labs, Inc.
- 510(k) number
- K243729
- Product code
- QFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-13
- Date received
- 2024-12-03
- Regulation
- 882.5803
- Classification name
- Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Robert (Bob) Schafer
- Address
- 16 Maiden Ln. Suite 600 San Francisco CA US 94108 94108
FDA Registration Numbers#
- 3013341423