Electrosurgical Coagulation For Aesthetic
The Electrosurgical Coagulation For Aesthetic (product code ONQ) is a Class 2 surgical device regulated under 21 CFR 878.4400 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is intended for the treatment of spider veins (telangiectasia) by thermocoagulation, delivering targeted electrical energy to ablate small visible blood vessels for aesthetic purposes. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- ONQ
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For the treatment of spider vein or telangiectasia by thermocoagulation.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K210077 | MED RF 4000 | Dec 17, 2021 | Substantially Equivalent | F Care Systems USA, LLC |
| K130283 | EVRF SYSTEM | Mar 07, 2013 | Substantially Equivalent | F Care Systems NV |
| K112334 | VEIN-GOGH INSTRUMENT | May 08, 2012 | Substantially Equivalent | Refine USA, LLC |
| K083352 | VEINWAVE, TC3000 | Jun 12, 2009 | Substantially Equivalent | Newlands Clinical Trials, Ltd. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.