Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sciton, Inc — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
255 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025-12-19 | 255 | 0 |
| K222958 | mJOULE RF System and Accessories | Sciton, Inc | 2024-04-23 | 574 | 0 |
| K213761 | Joule diVa System | Sciton, Inc | 2022-07-19 | 230 | 0 |
| K213350 | mJOULE System and Accessories | Sciton, Inc | 2022-04-15 | 189 | 0 |
| K182173 | Joule System | Sciton, Inc | 2019-03-06 | 208 | 0 |
| K180508 | JOULE SYSTEM | Sciton, Inc | 2018-05-18 | 81 | 0 |
| K173285 | JOULE SYSTEM | Sciton, Inc | 2018-01-29 | 105 | 0 |
| K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM | Sciton, Inc | 2013-06-19 | 300 | 0 |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | Sciton, Inc | 2011-12-07 | 190 | 0 |
| K101916 | JOULE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2011-03-18 | 252 | 0 |
| K081352 | PROFILE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2008-10-23 | 162 | 0 |
| K070388 | PROFILE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2007-05-02 | 82 | 0 |
| K060033 | PROFILE MULTI-PLATFORM SYSTEM | Sciton, Inc | 2006-02-28 | 54 | 0 |
| K040005 | PROFILE 2000/3000 LASER SYSTEM | Sciton, Inc | 2004-03-29 | 87 | 0 |
| K032459 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2004-03-09 | 211 | 0 |
| K032460 | PROFILE BBL SYSTEM | Sciton, Inc | 2003-11-13 | 94 | 0 |
| K023881 | PROFILE 1064 LASER SYSTEM | Sciton, Inc | 2003-06-13 | 204 | 0 |
| K022466 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2002-12-31 | 159 | 0 |
| K022381 | PROFILE 1320 LASER SYSTEM | Sciton, Inc | 2002-10-18 | 88 | 0 |
| K012552 | SCITON IMAGE HAIR REMOVAL LASER | Sciton, Inc | 2001-11-05 | 89 | 0 |
| K010285 | CONTOUR PROFILE LASER | Sciton, Inc | 2001-03-01 | 29 | 0 |
| K002853 | SCITON IMAGE HAIR REMOVAL LASER | Sciton, Inc | 2000-12-04 | 82 | 0 |
| K003046 | IMAGE VASCULAR LASER | Sciton, Inc | 2000-11-24 | 56 | 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