# K103498: Lakong Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Lakong Medical Device Company, Ltd.
- Decided: Mar 31, 2011 after 122 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Lakong 2200 Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Source page: https://510kreport.com/device/K103498
Methodology: https://510kreport.com/methodology