POWERLASER
Lamp, Infrared, Therapeutic Heating
POWERMEDIC APS
The following data is part of a premarket notification filed by Powermedic Aps with the FDA for Powerlaser.
Pre-market Notification Details
| Device ID | K070516 |
| 510k Number | K070516 |
| Device Name: | POWERLASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | POWERMEDIC APS KANALSTRAEDE 2 Holbaek, DK Dk-4300 |
| Contact | Arne Grinsted |
| Correspondent | Arne Grinsted POWERMEDIC APS KANALSTRAEDE 2 Holbaek, DK Dk-4300 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-22 |
| Decision Date | 2007-07-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05713592030120 | K070516 | 000 |
Trademark Results [POWERLASER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERLASER 88758858 not registered Live/Pending |
Powermedic US, Inc. 2020-01-14 |
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