Submission Details
| 510(k) Number | K181260 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 11, 2018 |
| Decision Date | June 21, 2019 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
MiiS Horus Scope DPT 100
Jun 2019
Decision
406d
Days
Class 2
Risk
About This 510(k) Submission
K181260 is an FDA 510(k) clearance for the MiiS Horus Scope DPT 100, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, CN). The FDA issued a Cleared decision on June 21, 2019, 406 days after receiving the submission on May 11, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.
Device Classification
| Product Code | HKX — Tonometer, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1930 |
Manufacturer
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