510(k) K181986
K181986 is an FDA 510(k) premarket notification submitted by Kea Products, Ltd. for the device "Klinly Ultrasonic Tongue Cleaner". The FDA issued a decision of Substantially Equivalent on September 6, 2019. The device falls under product code QIA (Powered Tongue Scraper), a Class I device regulated under 21 CFR 872.6865.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2019
- Date Received
- July 25, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Tongue Scraper
- Device Class
- Class I
- Regulation Number
- 872.6865
- Review Panel
- DE
- Submission Type
The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.