The following data is part of a premarket notification filed by Reimers And Janssen Gmbh with the FDA for Laserpen Practise And Expert, Handylaser Sprint, Handylaser Trion, Physiolaser Olympic, Polylaser.
| Device ID | K091675 |
| 510k Number | K091675 |
| Device Name: | LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | REIMERS AND JANSSEN GMBH LESSINGSTR. 79 Berlin, DE 13158 |
| Contact | Astrid Schulze |
| Correspondent | Astrid Schulze REIMERS AND JANSSEN GMBH LESSINGSTR. 79 Berlin, DE 13158 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-12-15 |