The following data is part of a premarket notification filed by Dermawave, Llc with the FDA for Dermawave 5000 Combi Max System.
| Device ID | K040121 |
| 510k Number | K040121 |
| Device Name: | DERMAWAVE 5000 COMBI MAX SYSTEM |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | DERMAWAVE, LLC 15693 83RD LANE NORTH Loxahatchee, FL 33470 |
| Contact | Alan Bunting |
| Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IMG |
| Subsequent Product Code | GXY |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | ILY |
| Subsequent Product Code | IMI |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-03-17 |
| Summary: | summary |