Ceragem Co Ltd · 89-08 · KOREA (THE REPUBLIC OF)
For Ceragem Co Ltd · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); 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 2026-09-16.
- 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) 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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