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
- 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
5Cited as predicate
2JOULE SYSTEM
UltraClear Laser System (N/A)
2 submissions cite K173285 as a predicate