510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wuhan DIMED LASER TECHNOLOGY CO., Ltd.

Wuhan Hubei, CN

Wuhan DIMED LASER TECHNOLOGY CO., LTD. appears in FDA device records in Wuhan Hubei, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Wuhan DIMED LASER TECHNOLOGY CO., Ltd. between 2021 and 2025. The busiest year on record is 2021, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Wuhan DIMED LASER TECHNOLOGY CO., Ltd., by decision year
YearClearances
20211
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)GEXSubstantially Equivalent
K211977Medical Diode Laser SystemsGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Wuhan DIMED LASER TECHNOLOGY CO., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30145770133014577013Wuhan DIMED LASER TECHNOLOGY CO., LTD.Room 202, Factory Building No. 17, East Lake High-tech Industry Innovation Base, Wuhan Hubei 430299 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain