# Wuhan Dimed Laser Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **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: appears in the quote below)_
- **Date published:** 07/08/2024 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).