# Totra Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Totra Co., Ltd. · 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 Callas Charming Double Eyelid Tape | Callas Charming Double Eyelid Tape; product code is 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 80 K - - GX Tape and Bandage, Adhesive; date published is 06/07/2017; address is 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Totra Co., Ltd. _(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:** 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 06/07/2017 _(verified: appears in the quote below)_
- **Product code:** 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 80 K - - GX Tape and Bandage, Adhesive _(verified: each item appears in the quote below)_
- **Product:** Callas Charming Double Eyelid Tape | Callas Charming Double Eyelid Tape _(verified: each item appears in the quote below)_
- **FDA notes:** Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin). | Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin). _(verified: each item appears in the quote below)_

## What the source says

> Totra Co., Ltd. Date Published : 06/07/2017 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) Date Published: 06/07/2017 Desc: Callas Charming Double Eyelid Tape Notes: Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin). 80 K - - GX Tape and Bandage, Adhesive Date Published: 06/07/2017 Desc: Callas Charming Double Eyelid Tape Notes: Device Classification is unknown. The Double Eyelid Tape appears to exceed the limitations of exemptions for 21CFR 880.5240 as the device is intended for a different intended use (i.e., to permanently reshape the eyelids rather than to cover/protect wounds, to hold together skin edges of a wound, to support an injured part of the body, or to secure objects to the skin).

## 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/).