510(k) K210077
K210077 is an FDA 510(k) premarket notification submitted by F Care Systems USA, LLC for the device "MED RF 4000". The FDA issued a decision of Substantially Equivalent on Dec 17, 2021. The device falls under product code ONQ (Electrosurgical Coagulation For Aesthetic), a Class II device regulated under 21 CFR 878.4400. F Care Systems USA, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 17, 2021
- Date Received
- Jan 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical Coagulation For Aesthetic
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
For the treatment of spider vein or telangiectasia by thermocoagulation.