The following data is part of a premarket notification filed by Curae'lase Inc. with the FDA for Cl10009 Ir Laser.
| Device ID | K130168 |
| 510k Number | K130168 |
| Device Name: | CL10009 IR LASER |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | CURAE'LASE INC. 12101 CULLEN BLVD., SUITE A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich CURAE'LASE INC. 12101 CULLEN BLVD., SUITE A Houston, TX 77047 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-24 |
| Decision Date | 2014-01-10 |