Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Home Skinovations , Ltd. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
382 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214078 | Silk’n Toothwave | Home Skinovations , Ltd. | 2023-01-13 | 382 | 0 |
| DEN190039 | ToothWave™ | Home Skinovations , Ltd. | 2020-09-17 | 392 | 0 |
| K180279 | Silk'n MODEL H5003 device | Home Skinovations , Ltd. | 2018-05-09 | 98 | 0 |
| K171433 | Silk'n Infinity | Home Skinovations , Ltd. | 2017-08-11 | 88 | 0 |
| K162784 | Silk'n HST | Home Skinovations , Ltd. | 2017-03-25 | 173 | 0 |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | 2016-07-29 | 368 | 0 |
| K150175 | HeatLux Pro I | Home Skinovations , Ltd. | 2015-03-31 | 64 | 0 |
| K141242 | GLIDE DEVICE | Home Skinovations , Ltd. | 2014-10-17 | 156 | 0 |
| K131870 | GLIDE DEVICE | Home Skinovations , Ltd. | 2013-08-14 | 51 | 0 |
| K121435 | SILKN BLUE | Home Skinovations , Ltd. | 2013-02-22 | 284 | 0 |
| K120582 | HEATLUX | Home Skinovations , Ltd. | 2012-07-06 | 130 | 0 |
| K110301 | SILK'N FX | Home Skinovations , Ltd. | 2011-08-19 | 198 | 0 |
| K103184 | SILK'N FLASH N GO | Home Skinovations , Ltd. | 2010-11-10 | 12 | 0 |
| K082298 | FLASH N' GO | Home Skinovations , Ltd. | 2008-10-23 | 72 | 0 |
| K072906 | SILK'N | Home Skinovations , Ltd. | 2008-01-23 | 104 | 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