GUANGZHOU GD BEAUTY EQUIPMENT · 89-08 · CHINA
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
- 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
- Pengshang Industrial Areapengshang Zhifu Road , Guangzhou, Guangdong CHINA verified
- Date published
- 08/22/2017 verified
- 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 each item verified
- Product
- Colorful LED Beauty Mask | Colorful LED Beauty Mask | Colorful LED Beauty Mask each item verified
- FDA notes
- Class II device without a valid 510K | Class II device without a valid 510K | Class II device without a valid 510K each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html