FDA 510(k) clearance · back to tracker

Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

Lakong Medical Devices Co., Ltd. cleared K251544 on 2026-08-07, decision: substantially equivalent

K-number

K251544

Sponsor

Lakong Medical Devices Co., Ltd.

Device

Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-08-07

Product code

EIA

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.6640

Official FDA record

Open K251544on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.