The following data is part of a premarket notification filed by Trophikos, Llc with the FDA for Trophikos Vaginal Moisturizer.
| Device ID | K201922 |
| 510k Number | K201922 |
| Device Name: | Trophikos Vaginal Moisturizer |
| Classification | Lubricant, Personal |
| Applicant | Trophikos, LLC 1212 Collier Rd NW Atlanta, GA 30318 |
| Contact | Terri Jackson Wade |
| Correspondent | Paul Dryden Trophikos, LLC C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-10 |
| Decision Date | 2021-01-14 |