Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carol Cole Company Dba Nuface® · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
177 daysmedian FDA review time
230 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240564 | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | 2024-06-27 | 119 | 0 |
| K212947 | Trinity Plus Wrinkle Reducer | Carol Cole Company Dba Nuface | 2022-04-02 | 199 | 0 |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | Carol Cole Company Dba Nuface | 2021-02-24 | 230 | 0 |
| K201782 | NuFace Trinity Plus Device | Carol Cole Company Dba Nuface | 2021-01-22 | 206 | 0 |
| K191672 | NuFACE Mini Device | Carol Cole Company Dba Nuface | 2019-10-15 | 113 | 0 |
| K182424 | NuFACE FIX Skin Toning Device | Carol Cole Company Dba Nuface | 2018-12-18 | 103 | 0 |
| K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018-10-11 | 177 | 0 |
| K171588 | NuBODY Skin Toning Device | Carol Cole Company Dba Nuface | 2017-07-31 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda