# Ceragem Co Ltd · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 16, Jeongjai-Gil, , Seonggeo-eup, Seobuk-gu , Cheonan-si, Chungcheongnam-Do KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 06/03/2015 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 79 O - - LP Over-the-counter powered red/blue light based laser for acne _(verified: each item appears in the quote below)_
- **Product:** OCimple Light Therapy System | OCimple Light Therapy System _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).