Capsulo
FDA 510(k) clearance K220430 · decided 2022-05-12
Clearance details
- K-number
- K220430
- Device name
- Capsulo
- Applicant
- Quantel Medical
- Decision
- Substantially Equivalent
- Date received
- 2022-02-15
- Decision date
- 2022-05-12
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cournon D'Auvergne-Cedex, FR
- Third-party review
- No
- Expedited review
- No
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| VISULAS combi (K233911) | Carl Zeiss Meditec, AG | 2024-09-06 |
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| Eagle device (K230722) | Belkin Vision, Ltd. | 2023-12-08 |
| VISULAS green (K232051) | Carl Zeiss Meditec | 2023-10-24 |
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Recalls involving this device
No recalls on record reference this clearance.