Submission Details
| 510(k) Number | K193188 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2019 |
| Decision Date | January 14, 2020 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
MiiS Horus Eye Anterior Camera
Jan 2020
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K193188 is an FDA 510(k) clearance for the MiiS Horus Eye Anterior Camera, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, CN). The FDA issued a Cleared decision on January 14, 2020, 57 days after receiving the submission on November 18, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.
Device Classification
| Product Code | HJO — Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1850 |
Manufacturer
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