The following data is part of a premarket notification filed by Isomers Laboratories Inc. with the FDA for Nutritone Facial Beauty System.
| Device ID | K070250 |
| 510k Number | K070250 |
| Device Name: | NUTRITONE FACIAL BEAUTY SYSTEM |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | ISOMERS LABORATORIES INC. 11 DELLCASTLE COURT Montgomery Village,, MD 20886 |
| Contact | Robert Mazzaferro |
| Correspondent | Robert Mazzaferro ISOMERS LABORATORIES INC. 11 DELLCASTLE COURT Montgomery Village,, MD 20886 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2008-09-04 |
| Summary: | summary |