COSRX INC · 89-08 · KOREA (THE REPUBLIC OF)
For COSRX INC · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); 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 2026-09-16.
- 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) 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html