Reimers & Janssen Gmbh · 89-08 · GERMANY
For Reimers & Janssen Gmbh, import alert is 89-08; country is GERMANY; 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 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 listed twice: 10/11/2013 and 08/30/2013; address is listed twice: Reichenbergerstrasse 147 , Berlin, Berlin GERMANY and Fabrikstr. 22 , Waldkirch, Baden-wurttemberg GERMANY, verified against its source on 2026-09-30.
- 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
- Fabrikstr. 22 , Waldkirch, Baden-wurttemberg GERMANY also listed
- Date published
- 10/11/2013 verified
- 08/30/2013 also listed
- 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
— 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
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.
— all from 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
— accessdata.fda.gov, retrieved 2026-09-15
Product code
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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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