Reimers & Janssen Gmbh · 89-08 · GERMANY
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
- 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
- Address
- Reichenbergerstrasse 147 , Berlin, Berlin GERMANY verified
- Date published
- 10/11/2013 verified
- 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 each item verified
- 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 each item verified
- 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. each item verified
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.
— accessdata.fda.gov, retrieved 2026-09-15
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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.