# COSRX INC · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** Bundangemtawo , 8 Gumi-Ro; Bundang , Seongnam, Gyeonggi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 09/04/2019 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## 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/).