Visibly Digital Acuity Product
FDA 510(k) clearance K220090 · decided 2022-08-12
Clearance details
- K-number
- K220090
- Device name
- Visibly Digital Acuity Product
- Applicant
- Visibly, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-11
- Decision date
- 2022-08-12
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- QTO
- Device class
- 1
- Regulation number
- 886.1150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.