The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Skin Pure.
| Device ID | K862799 |
| 510k Number | K862799 |
| Device Name: | SKIN PURE |
| Classification | Media, Electroconductive |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Diana Beal |
| Correspondent | Diana Beal NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | GYB |
| CFR Regulation Number | 882.1275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-22 |
| Decision Date | 1986-11-13 |