Manufacturer
Sciton, IncJoule System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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—
—
Not ingested
LASEMD Laser System
K182173 references 2 predicate/reference devices
Cited as predicate
2Lavieen
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
2 submissions cite K182173 as a predicate