Young Chemical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Young Chemical Co., Ltd., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 Acne Pimple Master Patch | Acne Pimple Master Patch; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 N - - AC Dressing, Wound, Hydrophilic; date published is 06/08/2017; address is 80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Young Chemical 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2017 verified
- Product code
- 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 79 N - - AC Dressing, Wound, Hydrophilic each item verified
- Product
- Acne Pimple Master Patch | Acne Pimple Master Patch each item verified
- FDA notes
- Class I device without a valid 510k | Class I device without a valid 510k each item verified
What the source says
Young Chemical Co., Ltd. Date Published : 06/08/2017 80-93 Golden Root-Ro , Juchon-Myeon , Gimhae-Si, Gyeongnam KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
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.
Product code, Product and FDA notes
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 06/08/2017 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 79 N - - AC Dressing, Wound, Hydrophilic Date Published: 06/08/2017 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html