Pfw Six Works Ltd · 89-08 · UNITED KINGDOM
For Pfw Six Works Ltd, import alert is 89-08; country is UNITED KINGDOM; 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 | 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 | 86 N - - UU Lens, Contact, Orthokeratology, Overnight; date published is 11/09/2012; address is Station Road , Cambridge, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Pfw Six Works Ltd 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
- UNITED KINGDOM verified
- Address
- Station Road , Cambridge, UNITED KINGDOM verified
- Date published
- 11/09/2012 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 | 86 N - - UU Lens, Contact, Orthokeratology, Overnight each item verified
- Product
- Contact Lenses | 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 | class II each item verified
What the source says
Pfw Six Works Ltd Date Published : 11/09/2012 Station Road , Cambridge, UNITED KINGDOM
— 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: 11/09/2012 Desc: Contact Lenses Notes: class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 M - - VN Lens, Contact (Disposable) Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II 86 N - - UU Lens, Contact, Orthokeratology, Overnight Date Published: 11/09/2012 Desc: Contact Lenses Notes: class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html