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JOULE SYSTEM

Sciton, Inc

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Sciton, Inc
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

5
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Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K173285
Device name
JOULE SYSTEM
Company
Sciton, Inc
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-10-16
Decision date
2018-01-29
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Skin resurfacingPigment treatmentVascular treatment
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

The JOULE 2940 nm Multi-Platform System with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, ablation and coagulation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

Intended Use

The JOULE 2940 nm Multi-Platform System with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, ablation and coagulation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

Summary parsed at:2026-06-01 05:56:31 UTC

Predicate devices

5

K173285 references 5 predicate/reference devices

Cited as predicate

2

2 submissions cite K173285 as a predicate