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

For Wuhan Dimed Laser Technology Co., Ltd., import alert is 89-08; country is CHINA; 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)"; product is EVANLAS Therapy Laser System | EVANLAS Therapy Laser System | REMY Medical Therapy Laser System | REMY Medical Therapy Laser System | EVANLAS Therapy Laser System | REMY Medical 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 2026-09-30.

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

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.