The following data is part of a premarket notification filed by Carol Cole Company with the FDA for Nuface, Model Nu-4003.
| Device ID | K072260 |
| 510k Number | K072260 |
| Device Name: | NUFACE, MODEL NU-4003 |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Carol Cole Company 3366 N. TORREY PINES CT. SUITE 130 La Jolla, CA 92037 |
| Contact | Howard Asher |
| Correspondent | Howard Asher Carol Cole Company 3366 N. TORREY PINES CT. SUITE 130 La Jolla, CA 92037 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-14 |
| Decision Date | 2007-11-27 |
| Summary: | summary |