The following data is part of a premarket notification filed by Cycle Clarity with the FDA for Follicle Clarity.
| Device ID | K212012 |
| 510k Number | K212012 |
| Device Name: | Follicle Clarity |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Cycle Clarity 1209 Fifteen Mile Landing Rd. Awendaw, SC 29429 |
| Contact | John Schnorr |
| Correspondent | John Schnorr Cycle Clarity 1209 Fifteen Mile Landing Rd. Awendaw, SC 29429 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2022-01-19 |