Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Viora , Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
152 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | Viora , Ltd. | 2020-12-09 | 121 | 0 |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | Viora , Ltd. | 2020-07-15 | 85 | 0 |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | Viora , Ltd. | 2020-05-21 | 85 | 0 |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | Viora , Ltd. | 2016-11-18 | 87 | 0 |
| K152611 | V20 system | Viora , Ltd. | 2016-02-19 | 158 | 0 |
| K150035 | V10 system | Viora , Ltd. | 2015-05-01 | 112 | 0 |
| K142093 | V20 SYSTEM | Viora , Ltd. | 2014-11-14 | 105 | 0 |
| K141904 | VIORA V-TOUCH | Viora , Ltd. | 2014-10-21 | 99 | 0 |
| K133837 | VIORA V-TOTAL | Viora , Ltd. | 2014-04-09 | 112 | 0 |
| K090221 | REACTION SYSTEM | Viora , Ltd. | 2009-07-01 | 152 | 0 |
| K090399 | TRIOS SYSTEM | Viora , Ltd. | 2009-06-10 | 113 | 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