COSRX INC · 89-08 · KOREA (THE REPUBLIC OF)
For COSRX INC, 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 | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch; product code is 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 64 D - - 01 Carboxymethylcellulose Sodium, Emollient,Lubricant | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 79 N - - AC Dressing, Wound, Hydrophilic | 79 N - - AD Dressing, Wound, Occlusive; date published is 09/04/2019; address is Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- COSRX INC 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
- Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 09/04/2019 verified
- Product code
- 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 64 D - - 01 Carboxymethylcellulose Sodium, Emollient,Lubricant | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 79 N - - AC Dressing, Wound, Hydrophilic | 79 N - - AD Dressing, Wound, Occlusive each item verified
- Product
- Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | Acne Pimple Master Patch | 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 | Class I device without a valid 510k | Class I device without a valid 510k | Class I device without a valid 510k | Class I device without a valid 510k | Class I device without a valid 510k | Class I device without a valid 510k each item verified
What the source says
COSRX INC Date Published : 09/04/2019 Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi 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 - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 09/04/2019 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 09/04/2019 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 09/04/2019 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 09/04/2019 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 64 D - - 01 Carboxymethylcellulose Sodium, Emollient,Lubricant Date Published: 09/04/2019 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/04/2019 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 79 N - - AC Dressing, Wound, Hydrophilic Date Published: 05/28/2021 Desc: Acne Pimple Master Patch Notes: Class I device without a valid 510k 79 N - - AD Dressing, Wound, Occlusive Date Published: 05/28/2021 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