K181986 is an FDA 510(k) clearance for the Klinly Ultrasonic Tongue Cleaner. This device is classified as a Powered Tongue Scraper (Class I - General Controls, product code QIA).
Submitted by Kea Products, Ltd. (Kwun Tong, HK). The FDA issued a Cleared decision on September 6, 2019, 408 days after receiving the submission on July 25, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6865. The Device Is Intended To Remove Debris From The Top Surface Of The Tongue As A Supplement To Normal Daily Oral Hygiene Care..
| 510(k) Number | K181986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2018 |
| Decision Date | September 06, 2019 |
| Days to Decision | 408 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | QIA - Powered Tongue Scraper |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6865 |
| Definition | The Device Is Intended To Remove Debris From The Top Surface Of The Tongue As A Supplement To Normal Daily Oral Hygiene Care. |