Totra Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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) 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).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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