510(k) K251544
K251544 is an FDA 510(k) premarket notification submitted by Lakong Medical Devices Co., Ltd. for the device "Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)". The FDA issued a decision of Substantially Equivalent on Aug 7, 2026. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Lakong Medical Devices Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 7, 2026
- Date Received
- May 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type
- 510(k)