Lakong Medical Devices Co., Ltd. FDA Record
- No warning letters matched by name
Lakong Medical Devices Co., Ltd. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lakong Medical Devices Co., Ltd." is on file.
- Latest 510(k)
- Sep 10, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Sep 10, 2026 |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Aug 7, 2026 |
Lakong Medical Devices Co., Ltd. and the FDA: common questions
Has Lakong Medical Devices Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Lakong Medical Devices Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Lakong Medical Devices Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Lakong Medical Devices Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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