510(k) K180895
- Device
- Alleye
- Applicant
- Oculocare Medical AG
- 510(k) number
- K180895
- Product code
- HOQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-27
- Date received
- 2018-04-05
- Regulation
- 886.1330
- Classification name
- Grid, Amsler
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lucas Bachmann
- Address
- Verena Conzett Strasse 9 Zurich CH ZH 8004 ZH 8004
FDA Registration Numbers#
- 1000391004
- 3013003882
- 3009410372
- 2518410
- 1820463
- 3016965632
- 9612297
- 3042228518
- 3016670763
Source Documents#
Other 510(k) Records For Product Code HOQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K143211 | myVision Track Model 005 | Vital Art and Science Incorporated | 2015-03-20 |
| K121738 | MYVISIONTRACK(TM) | Vital Art and Science Incorporated | 2013-02-22 |
| K014044 | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | Notal Vision, Inc. | 2002-03-04 |
| K874252 | KREDA DISC | Richmond Products, Inc. | 1988-01-27 |
| K863429 | MODIFIED DEVICE FOR SELF EXAMINATION OF EYES | Wheel Checkers | 1987-01-20 |
| K843227 | MACULAR FUNCTION ANALYZER | Danek Medical, Inc. | 1985-07-22 |
| K843702 | APPARATUS & METHODS SELF-EXAM OF EYE | Wheel Checkers | 1985-01-03 |
Legacy Summary#
summary
FDA Review#
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