May Pharm · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- 205-27 Gasan Digital , Seoul, KOREA (THE REPUBLIC OF) verified
- Date published
- 04/14/2025 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- Class III | Class III | Class III | Class III | Class III | Class III | Class III | Class III | Class III each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html