Sciton, Inc: FDA clearances and approvals
Sciton, Inc has 23 FDA 510(k) clearances (first 2000, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 159 days. Since 2017 its median was 208 days, against 98 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 14 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 300 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 93 |
| 2019 | 1 | 208 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 210 |
| 2023 | 0 | — |
| 2024 | 1 | 574 |
| 2025 | 1 | 255 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sciton, Inc's cleared 510(k)s took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 21 | 21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Sciton, Inc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251077 | JOULE 1064nm System and Accessories | GEX | 2025-12-19 | 255 |
| K222958 | mJOULE RF System and Accessories | GEI | 2024-04-23 | 574 |
| K213761 | Joule diVa System | GEX | 2022-07-19 | 230 |
| K213350 | mJOULE System and Accessories | GEX | 2022-04-15 | 189 |
| K182173 | Joule System | GEX | 2019-03-06 | 208 |
| K180508 | JOULE SYSTEM | GEX | 2018-05-18 | 81 |
| K173285 | JOULE SYSTEM | GEX | 2018-01-29 | 105 |
| K122567 | JOULE 810/940/980 MULTI-PLATFORM SYSTEM | GEX | 2013-06-19 | 300 |
| K111483 | JOULE CLEARSENSE LASER SYSTEM | PDZ | 2011-12-07 | 190 |
| K101916 | JOULE MULTI-PLATFORM SYSTEM | GEX | 2011-03-18 | 252 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sciton, Inc.
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.
Device clinical trials
Sciton, Inc is the industry lead sponsor of 14 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06363240: Evaluation of Broadband Light Treatment for Solar Lentigines (Completed, started 2024-03-12)
- NCT06389071: Laser Treatment for Lichen Sclerosus (Recruiting, started 2024-03-01)
- NCT05750901: Evaluation of Fractional Ablative Laser Treatment for Skin Conditions (Recruiting, started 2022-11-01)
- NCT05662592: Evaluation of Broadband Light Treatment Protocol for Pigmented Skin Lesions - A Comparative Study (Completed, started 2022-10-01)
- NCT05750914: Evaluation of Broadband Light Treatment for Pigmented Skin Lesions (Completed, started 2022-09-01)
Frequently asked questions
How many FDA 510(k) clearances does Sciton, Inc have?
Sciton, Inc has 23 FDA 510(k) clearances (first 2000, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Sciton, Inc's 510(k)s?
The median time from FDA receipt to decision across Sciton, Inc's cleared 510(k)s is 159 days. Since 2017: 208 days, versus 98 days for all cleared 510(k)s in the same product codes.
What devices does Sciton, Inc make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 21); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, 1).
Has Sciton, Inc had device recalls?
openFDA lists no recalls under a recalling firm name matching Sciton, Inc. Related entities may recall under other names.
Next steps
- See all 23 Sciton, Inc clearances with predicates and recalls
- Run predicate analysis for product code GEX, Sciton, Inc'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.