The following data is part of a premarket notification filed by Powermedic Aps with the FDA for Gigalaser.
| Device ID | K134017 |
| 510k Number | K134017 |
| Device Name: | GIGALASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | POWERMEDIC APS 12101 CULLEN BLVD SUITE A Houston, TX 77047 -2951 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich POWERMEDIC APS 12101 CULLEN BLVD SUITE A Houston, TX 77047 -2951 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GIGALASER 87705099 5508494 Live/Registered |
Powermedic US, Inc. 2017-12-01 |
![]() GIGALASER 77604214 3801724 Dead/Cancelled |
Powermedic US, Inc. 2008-10-30 |