Viora , Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Viora , Ltd.” (first 2009, latest 2020), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 112 days. Since 2017 the median was 85 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 105 |
| 2015 | 1 | 112 |
| 2016 | 2 | 122 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 85 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Viora , Ltd. took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| NUV | Massager, Vacuum, Light Induced Heating | 1 | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
Review panels
Most recent Viora , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202247 | V30 system, V20 system, V10 system, V-VR Hand piece | PBX | 2020-12-09 | 121 |
| K201064 | V30 System, V20 System, V10 System, V-FR Handpiece | PBX | 2020-07-15 | 85 |
| K200468 | V30 system, V20 system, V10 system, V-FC Handpiece | PBX | 2020-05-21 | 85 |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | GEX | 2016-11-18 | 87 |
| K152611 | V20 system | GEX | 2016-02-19 | 158 |
| K150035 | V10 system | PBX | 2015-05-01 | 112 |
| K142093 | V20 SYSTEM | GEX | 2014-11-14 | 105 |
| K141904 | VIORA V-TOUCH | GEI | 2014-10-21 | 99 |
| K133837 | VIORA V-TOTAL | GEX | 2014-04-09 | 112 |
| K090221 | REACTION SYSTEM | NUV | 2009-07-01 | 152 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Viora , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Viora , Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Viora , Ltd.” (first 2009, latest 2020), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Viora , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Viora , Ltd. is 112 days. Since 2017: 85 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Viora , Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 11 Viora , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Viora , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.