Beijing Winkonlaser Technology Limited FDA Record
Beijing Winkonlaser Technology Limited has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Beijing Winkonlaser Technology Limited" is on file.
- Latest 510(k)
- Aug 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 | 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 |
|---|---|---|
| K253790 | High Intensity Focused Electromagnetic Stimulation Device (FE60) | Aug 13, 2026 |
| K241860 | Diode Laser Hair Removal System | Sep 25, 2024 |
Beijing Winkonlaser Technology Limited and the FDA: common questions
Has Beijing Winkonlaser Technology Limited received an FDA warning letter?
No FDA warning letter addressed to the name "Beijing Winkonlaser Technology Limited" 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 Beijing Winkonlaser Technology Limited received an FDA Form 483?
FDA has not published a Form 483 for "Beijing Winkonlaser Technology Limited" in its reading room. FDA publishes some Form 483s, not all of them.
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