MYAH
FDA 510(k) clearance K222933 · decided 2023-06-29
Clearance details
- K-number
- K222933
- Device name
- MYAH
- Applicant
- Visia Imaging S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-26
- Decision date
- 2023-06-29
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- MXK
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Giovanni Valdarno, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Pentacam® Cornea OCT (K251848) | Oculus Optikgeräte GmbH | 2026-03-13 |
| Tomey Optical Biometer OA-2000 (OA-2000) (K252348) | Tomey Corporation | 2025-12-18 |
| BOSS™ (K223700) | Intelon Optics, Inc. | 2024-08-16 |
| MYAH (K211868) | Visia Imaging S.R.L. | 2022-03-01 |
| Myopia Master (K202989) | Oculus Optikgeräte GmbH | 2021-07-14 |
| Pentacam AXL Wave (K201724) | Oculus Optikgerate GmbH | 2020-10-21 |
| Galilei G6 Lens Professional (K182659) | Sis Ag, Surgical Instrument Systems | 2019-07-25 |
| ARGOS (K191051) | Santec Corporation | 2019-05-16 |
| Pentacam AXL (K152311) | Oculus Optikgerate GmbH | 2016-01-20 |
| ARGOS (K150754) | Santec Corporation | 2015-10-02 |
| PARKONE (K073508) | Oculus Optikgerate GmbH | 2008-09-11 |
| ALLEGRO OCULYZER (K071183) | Wavelight AG | 2007-07-20 |
Recalls involving this device
No recalls on record reference this clearance.