Shenzhen Bway Tech Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 1 Latest Oct 26, 2026

Shenzhen Bway Tech Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Shenzhen Bway Tech Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Shenzhen Bway Tech Co., Ltd." and its spelling variant "Shenzhen Bway Tech Co".

Latest 510(k)
Oct 26, 2026

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances1Nov 15, 2026File dated Nov 9, 2026Current
Inspections0Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

1 510(k) clearance on Oct 26, 2026.

K-NumberDeviceDate
K262984Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05…Oct 26, 2026

Shenzhen Bway Tech Co., Ltd. and the FDA: common questions

Has Shenzhen Bway Tech Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Shenzhen Bway Tech 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 Shenzhen Bway Tech Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Shenzhen Bway Tech Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.