Radiancy (Israel) , Ltd.: FDA clearances and approvals
Radiancy (Israel) , Ltd. has 11 FDA 510(k) clearances (first 2002, latest 2010), across 2 product codes in 1 review panel. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 10 | 10 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
Most recent Radiancy (Israel) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102477 | NO!NO! SKIN | OLP | 2010-10-04 | 35 |
| K082423 | NO!NO! SKIN | GEX | 2008-12-03 | 103 |
| K072331 | RADIANCY MISTRAL DEVICE | GEX | 2008-01-07 | 140 |
| K060411 | RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM | GEX | 2006-03-22 | 34 |
| K052991 | RADIANCY FACIAL SKINCARE DEVICE | GEX | 2006-02-01 | 99 |
| K052442 | RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY | GEX | 2006-01-26 | 142 |
| K051671 | RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY | GEX | 2005-09-02 | 72 |
| K032205 | RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY | GEX | 2003-12-11 | 146 |
| K033181 | SPR SYSTEM | GEX | 2003-10-24 | 23 |
| K030897 | SKINSTATION | GEX | 2003-06-19 | 90 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radiancy (Israel) , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Radiancy (Israel) , Ltd. have?
Radiancy (Israel) , Ltd. has 11 FDA 510(k) clearances (first 2002, latest 2010), across 2 product codes in 1 review panel.
How long does FDA take to clear Radiancy (Israel) , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Radiancy (Israel) , Ltd.'s cleared 510(k)s is 90 days.
What devices does Radiancy (Israel) , Ltd. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 10); OLP (Over-The-Counter Powered Light Based Laser For Acne, 1).
Has Radiancy (Israel) , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Radiancy (Israel) , Ltd. Related entities may recall under other names.
Next steps
- See all 11 Radiancy (Israel) , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Radiancy (Israel) , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.