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

For May Pharm · 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 Cross-linked Hyaluronic Acid | METOO Fill Deep; Cross-linked Hyaluronic Acid | METOO Fill Volume | METOO Fill Volume | METOO Fill Deep; Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | METOO Fill Volume | Cross-linked Hyaluronic Acid | METOO Fill Deep; Cross-linked Hyaluronic Acid; product code is 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 04/14/2025; address is 205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** May Pharm _(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:** 205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/14/2025 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: each item appears in the quote below)_
- **Product:** Cross-linked Hyaluronic Acid | METOO Fill Deep; Cross-linked Hyaluronic Acid | METOO Fill Volume | METOO Fill Volume | METOO Fill Deep; Cross-linked Hyaluronic Acid | Cross-linked Hyaluronic Acid | METOO Fill Volume | Cross-linked Hyaluronic Acid | METOO Fill Deep; Cross-linked Hyaluronic Acid _(verified: each item appears in the quote below)_
- **FDA notes:** Class III | Class III | Class III | Class III | Class III | Class III | Class III | Class III | Class III _(verified: each item appears in the quote below)_

## What the source says

> May Pharm Date Published : 04/14/2025 205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF) 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/14/2025 Desc: Cross-linked Hyaluronic Acid Notes: Class III 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/14/2025 Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 04/14/2025 Desc: METOO Fill Volume Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/14/2025 Desc: METOO Fill Volume Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/14/2025 Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III 79 L - - MH Implant, Dermal, Collagen for Aesthetic Use Date Published: 04/14/2025 Desc: Cross-linked Hyaluronic Acid Notes: Class III 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/14/2025 Desc: METOO Fill Volume Notes: Class III 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/14/2025 Desc: Cross-linked Hyaluronic Acid Notes: Class III 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 04/14/2025 Desc: METOO Fill Deep; Cross-linked Hyaluronic Acid Notes: Class III

## 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/).