Keyue (Hangzhou) Medical Information Technology Co., Ltd. FDA Record
- No warning letters matched by name
Keyue (Hangzhou) Medical Information Technology Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Keyue (Hangzhou) Medical Information Technology Co., Ltd." is on file.
- Latest 510(k)
- Oct 13, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | 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 |
|---|---|---|
| K261572 | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) | Oct 13, 2026 |
Keyue (Hangzhou) Medical Information Technology Co., Ltd. and the FDA: common questions
Has Keyue (Hangzhou) Medical Information Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Keyue (Hangzhou) Medical Information Technology 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 Keyue (Hangzhou) Medical Information Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Keyue (Hangzhou) Medical Information Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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