G & G Contact Lens Co. · 89-08 · KOREA (THE REPUBLIC OF)
For G & G Contact Lens Co., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 Soft cosmetic contact lenses | Soft cosmetic contact lenses | Soft cosmetic contact lenses | Soft cosmetic contact lenses | Contact Lens | Soft cosmetic contact lenses | Circle Lenses | Soft cosmetic contact lenses | Soft cosmetic contact lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 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 M - - ZD System, In-Office Tinting, Contact Lenses | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 11/18/2011; address is 4 Fl., Bummel Building 1287-1 , Bummel-Dong, Susung-Gu , Daegu, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- G & G Contact Lens Co. 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 4 Fl., Bummel Building 1287-1 , Bummel-Dong, Susung-Gu , Daegu, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/18/2011 verified
- Product code
- 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 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 M - - ZD System, In-Office Tinting, Contact Lenses | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort each item verified
- Product
- Soft cosmetic contact lenses | Soft cosmetic contact lenses | Soft cosmetic contact lenses | Soft cosmetic contact lenses | Contact Lens | Soft cosmetic contact lenses | Circle Lenses | Soft cosmetic contact lenses | Soft cosmetic contact lenses each item verified
- FDA notes
- class II/III | Class II; 7/27/2010 each item verified
What the source says
G & G Contact Lens Co. Date Published : 11/18/2011 4 Fl., Bummel Building 1287-1 , Bummel-Dong, Susung-Gu , Daegu, KOREA (THE REPUBLIC OF)
— 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: 02/03/2016 Desc: Soft cosmetic contact lenses 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 02/03/2016 Desc: Soft cosmetic contact lenses 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 02/03/2016 Desc: Soft cosmetic contact lenses 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 02/03/2016 Desc: Soft cosmetic contact lenses 86 M - - VN Lens, Contact (Disposable) Date Published: 11/18/2011 Desc: Contact Lens Notes: class II/III 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 02/03/2016 Desc: Soft cosmetic contact lenses 86 M - - ZD System, In-Office Tinting, Contact Lenses Date Published: 01/30/2019 Desc: Circle Lenses Notes: Class II; 7/27/2010 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 02/03/2016 Desc: Soft cosmetic contact lenses 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 02/03/2016 Desc: Soft cosmetic contact lenses
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html