Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)— 510(k) K251544
Substantially EquivalentLakong Medical Devices Co., Ltd.
FDA 510(k) clearance K251544 for Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0), Substantially Equivalent on 2026-08-07. Applicant: Lakong Medical Devices Co., Ltd.. Device class: 1.
Summary
Lakong Medical Devices filed a Dental Unit in two listed models, MP2000-550LED-2.0 and LP2100-550LED-2.0. The product code is EIA, operative dental units.
Class I, 21 CFR 872.6640. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
Lakong filed from Dongguan, China. The decision came 444 calendar days after receipt (May 20, 2025 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Lakong Medical Devices Co., Ltd.
- Product code
- Product code EIA
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
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