# BESTYLE GIFT & PAC · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For BESTYLE GIFT & PAC · 89-08 · CHINA, 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 CHINA; product is Heated Dry Eye Mask | Heated Dry Eye Mask; product code is 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) | 86 O - - RZ Lipiflow thermal pulsation system, EYELID THERMAL PULSATION SYSTEM; date published is 03/17/2021; address is Room 515 , Blk 1 C , Shenzhen, CHINA, verified against its source on 2026-09-16.

- **Firm:** BESTYLE GIFT & PAC _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** Room 515 , Blk 1 C , Shenzhen, CHINA _(verified: appears in the quote below)_
- **Date published:** 03/17/2021 _(verified: appears in the quote below)_
- **Product code:** 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) | 86 O - - RZ Lipiflow thermal pulsation system, EYELID THERMAL PULSATION SYSTEM _(verified: each item appears in the quote below)_
- **Product:** Heated Dry Eye Mask | Heated Dry Eye Mask _(verified: each item appears in the quote below)_
- **FDA notes:** Providing 510(k) may not be sufficient to overcome the appearance of violation. | Providing 510(k) may not be sufficient to overcome the appearance of violation. _(verified: each item appears in the quote below)_

## What the source says

> BESTYLE GIFT & PAC Date Published : 03/17/2021 Room 515 , Blk 1 C , Shenzhen, CHINA 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 03/17/2021 Desc: Heated Dry Eye Mask Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation. 86 O - - RZ Lipiflow thermal pulsation system, EYELID THERMAL PULSATION SYSTEM Date Published: 03/17/2021 Desc: Heated Dry Eye Mask Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.

## 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/).