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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

2
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Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K182173
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
2018-08-10
Decision date
2019-03-06
Submission type
Traditional
Technology type
Thulium fiber(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentSkin resurfacingOther
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The JOULE 1927 nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Intended Use

The JOULE 1927nm Laser System with its accessories is intended for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Summary parsed at:2026-06-01 05:54:42 UTC

Predicate devices

2

K182173 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K182173 as a predicate