Manufacturer
Sciton, IncJoule diVa System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K213761
- Device name
- Joule diVa System
- Company
- Sciton, Inc
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-12-01
- Decision date
- 2022-07-19
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatmentSkin resurfacingSurgical cuttingOther
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The JOULE 1470 nm Multi-Platform Systems with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. General Surgery: The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation. Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. The MCL 31 Dermablate system with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures. The JOULE diVa Laser Device with its accessories is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Intended Use
The JOULE diVa Laser Device with its accessories is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.
Summary parsed at:2026-06-01 05:39:14 UTC
Predicate devices
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Not ingested
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Not ingested
MCL 31 Dermablate System
K213761 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K213761 as a predicate
