Clearance Summary
Visibly Digital Acuity Product received FDA 510(k) clearance under submission number K220090, sponsored by Visibly, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2022-08-12.
- Submission: K220090
- Applicant / Sponsor: Visibly, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1150
- Decision date: 2022-08-12
Classification & Regulation
This clearance is catalogued under FDA product code QTO and 21 CFR 886.1150, within the Ophthalmic review panel as a Class I device.