Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Radiancy (Israel) , Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
142 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102477 | NO!NO! SKIN | Radiancy (Israel) , Ltd. | 2010-10-04 | 35 | 0 |
| K082423 | NO!NO! SKIN | Radiancy (Israel) , Ltd. | 2008-12-03 | 103 | 0 |
| K072331 | RADIANCY MISTRAL DEVICE | Radiancy (Israel) , Ltd. | 2008-01-07 | 140 | 0 |
| K060411 | RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM | Radiancy (Israel) , Ltd. | 2006-03-22 | 34 | 0 |
| K052991 | RADIANCY FACIAL SKINCARE DEVICE | Radiancy (Israel) , Ltd. | 2006-02-01 | 99 | 0 |
| K052442 | RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY | Radiancy (Israel) , Ltd. | 2006-01-26 | 142 | 0 |
| K051671 | RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY | Radiancy (Israel) , Ltd. | 2005-09-02 | 72 | 0 |
| K032205 | RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY | Radiancy (Israel) , Ltd. | 2003-12-11 | 146 | 0 |
| K033181 | SPR SYSTEM | Radiancy (Israel) , Ltd. | 2003-10-24 | 23 | 0 |
| K030897 | SKINSTATION | Radiancy (Israel) , Ltd. | 2003-06-19 | 90 | 0 |
| K020856 | SPATOUCH PHOTOEPILATION SYSTEM | Radiancy (Israel) , Ltd. | 2002-06-13 | 90 | 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