BESTYLE GIFT & PAC · 89-08 · CHINA
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
- 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 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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