BESTYLE GIFT & PAC · 89-08 · CHINA
For BESTYLE GIFT & PAC, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- Firm
- BESTYLE GIFT & PAC 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
- CHINA verified
- Address
- Room 515 , Blk 1 C , Shenzhen, CHINA verified
- Date published
- 03/17/2021 verified
- 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 each item verified
- Product
- Heated Dry Eye Mask | Heated Dry Eye Mask each item verified
- 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. each item verified
What the source says
BESTYLE GIFT & PAC Date Published : 03/17/2021 Room 515 , Blk 1 C , Shenzhen, CHINA
— 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
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html