Ceragem Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Ceragem Co Ltd, 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 OCimple Light Therapy System | OCimple Light Therapy System; product code is 79 G - - EX Powered laser surgical instruments | 79 O - - LP Over-the-counter powered red/blue light based laser for acne; date published is 06/03/2015; address is 16, Jeongjai-Gil, , Seonggeo-eup, Seobuk-gu , Cheonan-si, Chungcheongnam-Do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- Ceragem Co 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 16, Jeongjai-Gil, , Seonggeo-eup, Seobuk-gu , Cheonan-si, Chungcheongnam-Do KOREA (THE REPUBLIC OF) verified
- Date published
- 06/03/2015 verified
- Product code
- 79 G - - EX Powered laser surgical instruments | 79 O - - LP Over-the-counter powered red/blue light based laser for acne each item verified
- Product
- OCimple Light Therapy System | OCimple Light Therapy System each item verified
- FDA notes
- class II | class II each item verified
What the source says
Ceragem Co Ltd Date Published : 06/03/2015 16, Jeongjai-Gil, , Seonggeo-eup, Seobuk-gu , Cheonan-si, Chungcheongnam-Do 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
79 G - - EX Powered laser surgical instruments Date Published: 06/03/2015 Desc: OCimple Light Therapy System Notes: class II 79 O - - LP Over-the-counter powered red/blue light based laser for acne Date Published: 06/03/2015 Desc: OCimple Light Therapy System 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