Product areas
FDA product code distribution
Sciton, Inc
Country / region:United States (US)
510(k) submissions
6
Filtered: GEX
Latest clearance
2025-12-19
Product codes
1
GEX
510(k) submissions
6 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K251077 | JOULE 1064nm System and Accessories | GEX | Class 2 | 2025-12-19 |
| K213761 | Joule diVa System | GEX | Class 2 | 2022-07-19 |
| K213350 | mJOULE System and Accessories | GEX | Class 2 | 2022-04-15 |
| K182173 | Joule System | GEX | Class 2 | 2019-03-06 |
| K180508 | JOULE SYSTEM | GEX | Class 2 | 2018-05-18 |
| K173285 | JOULE SYSTEM | GEX | Class 2 | 2018-01-29 |
Company profile
- Canonical name
- Sciton, Inc
- Country
- United States(US)
Cited predicates
18- K063748
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Not ingested - K122567
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Not ingested - K023881
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Not ingested - K060033
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Not ingested - K101916
—
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Not ingested - K210634
MCL 31 Dermablate System
- K023881
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Not ingested - K182088
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
- K191842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
- K130193
—
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Not ingested - K171009
LASEMD Laser System
- K111303
—
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Not ingested - K173285
JOULE SYSTEM
- K081352
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Not ingested - K100270
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Not ingested - K101916
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Not ingested - K110907
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Not ingested - K142376
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Not ingested
Sciton, Inc references 18 predicate/reference devices