The following data is part of a premarket notification filed by Technological Medical Advancments, Inc. (tma) with the FDA for Diowave Low Level Cold Laser System.
| Device ID | K121363 |
| 510k Number | K121363 |
| Device Name: | DIOWAVE LOW LEVEL COLD LASER SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA) 1209 NORTH FLAGLER DRIVE West Palm Beach, FL 33401 |
| Contact | Bruce Coren |
| Correspondent | Bruce Coren TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA) 1209 NORTH FLAGLER DRIVE West Palm Beach, FL 33401 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-11-23 |
| Summary: | summary |