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FDA 510(k)

LAKONG ULTRASONIC SCALER

K-Number: K103498 · 2011-03-31

ApplicantLakong Medical Device Company, Ltd.
Decision Date2011-03-31
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LAKONG ULTRASONIC SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Lakong Medical Device Company, Ltd.. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K103498. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAKONG ULTRASONIC SCALER?

LAKONG ULTRASONIC SCALER is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Lakong Medical Device Company, Ltd.. The 510(k) number is K103498.

When did LAKONG ULTRASONIC SCALER receive FDA 510(k) clearance?

LAKONG ULTRASONIC SCALER received FDA 510(k) clearance on 2011-03-31, under 510(k) number K103498.

Who is the listed applicant for LAKONG ULTRASONIC SCALER?

The FDA 510(k) record lists Lakong Medical Device Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAKONG ULTRASONIC SCALER?

The FDA product code for LAKONG ULTRASONIC SCALER is ELC.

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Related Devices (Code: ELC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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