# GUANGZHOU GD BEAUTY EQUIPMENT · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For GUANGZHOU GD BEAUTY EQUIPMENT · 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 Colorful LED Beauty Mask | Colorful LED Beauty Mask | Colorful LED Beauty Mask; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - LP Over-the-counter powered red/blue light based laser for acne; date published is 08/22/2017; address is Pengshang Industrial Areapengshang Zhifu Road , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** GUANGZHOU GD BEAUTY EQUIPMENT _(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:** Pengshang Industrial Areapengshang Zhifu Road , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 08/22/2017 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 O - - HS Light Based over the counter wrinkle reduction | 79 O - - LP Over-the-counter powered red/blue light based laser for acne _(verified: each item appears in the quote below)_
- **Product:** Colorful LED Beauty Mask | Colorful LED Beauty Mask | Colorful LED Beauty Mask _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device without a valid 510K | Class II device without a valid 510K | Class II device without a valid 510K _(verified: each item appears in the quote below)_

## What the source says

> GUANGZHOU GD BEAUTY EQUIPMENT Date Published : 08/22/2017 Pengshang Industrial Areapengshang Zhifu Road , Guangzhou, Guangdong CHINA 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 08/22/2017 Desc: Colorful LED Beauty Mask Notes: Class II device without a valid 510K 79 O - - HS Light Based over the counter wrinkle reduction Date Published: 08/22/2017 Desc: Colorful LED Beauty Mask Notes: Class II device without a valid 510K 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 08/22/2017 Desc: Colorful LED Beauty Mask Notes: Class II device without a valid 510K

## 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/).