K181260 is an FDA 510(k) clearance for the MiiS Horus Scope DPT 100. This device is classified as 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 FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K181260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | HKX - Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |