Totra Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Totra Co., Ltd., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.
- Firm
- Totra Co., Ltd. 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
- 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF) verified
- Date published
- 06/07/2017 verified
- Product code
- 53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations) | 80 K - - GX Tape and Bandage, Adhesive each item verified
- Product
- Callas Charming Double Eyelid Tape | Callas Charming Double Eyelid Tape each item verified
- 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). each item verified
What the source says
Totra Co., Ltd. Date Published : 06/07/2017 248 Jeosantaeseong-Ro , Heungdeok , Cheongju, Chungcheongbuk KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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).
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html