Reference Source

Aspiration Intl · 89-08 · HONG KONG SAR

For Aspiration Intl, import alert is 89-08; country is HONG KONG SAR; 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 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 listed twice: Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR and Unit 206 Blk B Hi Tech Ind Ctr491-501 , Tsuen Wantsuen Wan, HONG KONG SAR, verified against its source on 2026-09-30.

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
Unit 206 Blk B Hi Tech Ind Ctr491-501 , Tsuen Wantsuen Wan, HONG KONG SAR also listed
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

— 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 - - 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

— all from 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

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

Product code

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

Source

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

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