Alleye
FDA 510(k) clearance K180895 · decided 2018-06-27
Clearance details
- K-number
- K180895
- Device name
- Alleye
- Applicant
- Oculocare Medical AG
- Decision
- Substantially Equivalent
- Date received
- 2018-04-05
- Decision date
- 2018-06-27
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- HOQ
- Device class
- 1
- Regulation number
- 886.1330
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Zurich, CH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| myVision Track Model 005 (K143211) | Vital Art and Science Incorporated | 2015-03-20 |
| MYVISIONTRACK(TM) (K121738) | Vital Art and Science Incorporated | 2013-02-22 |
| MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (K014044) | Notal Vision, Inc. | 2002-03-04 |
| KREDA DISC (K874252) | Richmond Products, Inc. | 1988-01-27 |
| MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (K863429) | Wheel Checkers | 1987-01-20 |
| MACULAR FUNCTION ANALYZER (K843227) | Danek Medical, Inc. | 1985-07-22 |
| APPARATUS & METHODS SELF-EXAM OF EYE (K843702) | Wheel Checkers | 1985-01-03 |
Recalls involving this device
No recalls on record reference this clearance.