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510(k) Data Aggregation
K Number
K181986Device Name
Klinly Ultrasonic Tongue Cleaner
Manufacturer
Date Cleared
2019-09-06
(408 days)
Product Code
Regulation Number
872.6865Why did this record match?
Product Code :
QIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.
Device Description
The Klinly Ultrasonic Tongue Cleaner is a battery-operated device intended to be used to supplement daily oral hygiene care. It operates on two (2) AAA Alkaline batteries. All user-contacting components of the Klinly Ultrasonic Tongue Cleaner are constructed of injection-molded plastics which have demonstrated substantially equivalent biocompatibility according to ISO 10993-1.
The Klinly Ultrasound Tongue Cleaner device is comprised of three principles of operation to supplement daily oral hygiene by tongue cleaning. The device has a tongue scraping head, which:
- (1) Operates manually as a standard manual tonque scraper
- (2) Produces a low-frequency tactile vibration at 233 Hz, and
- (3) Emits ultrasound pressure waves at 1.6 MHz frequency.
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