# Reimers & Janssen Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Reimers & Janssen Gmbh · 89-08 · GERMANY, 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 GERMANY; product is Infrared/Laser 70MW/785NM Laser Pen Devices | Infrared/Laser 70MW/785NM Laser Pen Devices | Infrared/Laser 70MW/785NM laser Pen Devices | Infrared/Laser 70MW/785NM laser Pen Devices; product code is 68 Z - - 99 Animal Medical Devices, NEC | 79 G - - EX Powered laser surgical instruments | 89 I - - LY Lamp, infrared, therapeutic heating | 95 R - - DW General Purpose Laser Products, Non-Medical; date published is 10/11/2013; address is Reichenbergerstrasse 147 , Berlin, Berlin GERMANY, verified against its source on 2026-09-16.

- **Firm:** Reimers & Janssen Gmbh _(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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Reichenbergerstrasse 147 , Berlin, Berlin GERMANY _(verified: appears in the quote below)_
- **Date published:** 10/11/2013 _(verified: appears in the quote below)_
- **Product code:** 68 Z - - 99 Animal Medical Devices, NEC | 79 G - - EX Powered laser surgical instruments | 89 I - - LY Lamp, infrared, therapeutic heating | 95 R - - DW General Purpose Laser Products, Non-Medical _(verified: each item appears in the quote below)_
- **Product:** Infrared/Laser 70MW/785NM Laser Pen Devices | Infrared/Laser 70MW/785NM Laser Pen Devices | Infrared/Laser 70MW/785NM laser Pen Devices | Infrared/Laser 70MW/785NM laser Pen Devices _(verified: each item appears in the quote below)_
- **FDA notes:** Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. | Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. | Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. | Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. _(verified: each item appears in the quote below)_

## What the source says

> Reimers & Janssen Gmbh Date Published : 10/11/2013 Reichenbergerstrasse 147 , Berlin, Berlin GERMANY 68 Z - - 99 Animal Medical Devices, NEC Date Published: 03/12/2024 Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. 79 G - - EX Powered laser surgical instruments Date Published: 03/12/2024 Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 10/11/2013 Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. 95 R - - DW General Purpose Laser Products, Non-Medical Date Published: 10/11/2013 Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

## The same source also states

> Reimers & Janssen Gmbh Date Published : 08/30/2013 Fabrikstr. 22 , Waldkirch, Baden-wurttemberg GERMANY 68 Z - - 99 Animal Medical Devices, NEC Date Published: 03/12/2024 Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. 79 G - - EX Powered laser surgical instruments Date Published: 03/12/2024 Desc: Infrared/Laser 70MW/785NM Laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 08/30/2013 Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use. 95 R - - DW General Purpose Laser Products, Non-Medical Date Published: 10/11/2013 Desc: Infrared/Laser 70MW/785NM laser Pen Devices Notes: Class II; Note; Promotional language for acupressure; laser acupressure; arthritis and dental applications are not cleared and require a new 510(k). Product may come in labeled as for animal use.

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

## 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/).