Reference Source

Aspiration Intl · 89-08 · HONG KONG SAR

For Aspiration Intl · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 10/29/2010; address is Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR, verified against its source on 2026-09-16.

Firm
Aspiration Intl 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
HONG KONG SAR verified
Address
Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR verified
Date published
10/29/2010 verified
Product code
86 H - - PX Lens, Contact (Polymethylmethacrylate) | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort each item verified
Product
Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses | Contact lenses each item verified
FDA notes
class II | class II | class II | class II | class II | Class II | class II | class II | class II each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Aspiration Intl Date Published : 10/29/2010 Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 M - - VN Lens, Contact (Disposable) Date Published: 10/29/2010 Desc: Contact lenses Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 10/29/2010 Desc: Contact lenses Notes: class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 10/29/2010 Desc: Contact lenses Notes: class II

— accessdata.fda.gov, retrieved 2026-09-15

The same source also states

Aspiration Intl Date Published : 10/29/2010 Unit 206 Blk B Hi Tech Ind Ctr491-501 , Tsuen Wantsuen Wan, HONG KONG SAR 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 M - - VN Lens, Contact (Disposable) Date Published: 10/29/2010 Desc: Contact Lenses Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 10/29/2010 Desc: Contact Lenses Notes: class II

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.

More on food, drink and consumer products

All 27 datasets on this subject · Look something up