Reference Source

Wuhan Dimed Laser Technology Co., Ltd. · 89-08 · CHINA

For Wuhan Dimed Laser Technology Co., Ltd. · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | REMY Medical Therapy Laser System | REMY Medical Therapy Laser System | REMY Medical Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | REMY Medical Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System; product code is 74 L - - WX Device, Laser Peripheral Angioplasty | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 P - - DZ Lasers for temporary increase of clear nail in patients with onychomycosis | 84 L - - LP Laser For Pain Therapy, Laser For Pain Therapy | 84 L - - LP Laser For Pain Therapy, Laser For Pain Therapy | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 95 R - - AA Laser products (pre-standard) | 95 R - - DW General Purpose Laser Products, Non-Medical | 95 R - - FM Laser-Based Material Positioning Systems | 95 R - - HL Laser therapy product; date published is 07/08/2024; address is Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1 Minzu Avenue, , Wuhan East Lake High-Tech Development Zone , Wuhan, Hubei CHINA, verified against its source on 2026-09-16.

Firm
Wuhan Dimed Laser Technology Co., Ltd. verified
Import alert
89-08
Import alert name
"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
Country
CHINA verified
Address
Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1 Minzu Avenue, , Wuhan East Lake High-Tech Development Zone , Wuhan, Hubei CHINA verified
Date published
07/08/2024 verified
Product code
74 L - - WX Device, Laser Peripheral Angioplasty | 79 G - - EX Powered laser surgical instruments | 79 G - - EX Powered laser surgical instruments | 79 P - - DZ Lasers for temporary increase of clear nail in patients with onychomycosis | 84 L - - LP Laser For Pain Therapy, Laser For Pain Therapy | 84 L - - LP Laser For Pain Therapy, Laser For Pain Therapy | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 95 R - - AA Laser products (pre-standard) | 95 R - - DW General Purpose Laser Products, Non-Medical | 95 R - - FM Laser-Based Material Positioning Systems | 95 R - - HL Laser therapy product each item verified
Product
EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | REMY Medical Therapy Laser System | REMY Medical Therapy Laser System | REMY Medical Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | REMY Medical Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | EVANLAS Therapy Laser System each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Wuhan Dimed Laser Technology Co., Ltd. Date Published : 07/08/2024 Room 311, 313, 315, Hubei Guozhi Patent Venture Incubator Building, 327-1 Minzu Avenue, , Wuhan East Lake High-Tech Development Zone , Wuhan, Hubei CHINA 74 L - - WX Device, Laser Peripheral Angioplasty Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 79 G - - EX Powered laser surgical instruments Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 79 G - - EX Powered laser surgical instruments Date Published: 10/31/2025 Desc: REMY Medical Therapy Laser System Notes: 79 P - - DZ Lasers for temporary increase of clear nail in patients with onychomycosis Date Published: 10/31/2025 Desc: REMY Medical Therapy Laser System Notes: 84 L - - LP Laser For Pain Therapy, Laser For Pain Therapy Date Published: 10/31/2025 Desc: REMY Medical Therapy Laser System Notes: 84 L - - LP Laser For Pain Therapy, Laser For Pain Therapy Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 10/31/2025 Desc: REMY Medical Therapy Laser System Notes: 95 R - - AA Laser products (pre-standard) Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 95 R - - DW General Purpose Laser Products, Non-Medical Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 95 R - - FM Laser-Based Material Positioning Systems Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System 95 R - - HL Laser therapy product Date Published: 07/08/2024 Desc: EVANLAS Therapy Laser System

— accessdata.fda.gov, retrieved 2026-09-15

Source

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