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VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)

K052003 Class II Traditional
Decision Date
2005-10-11
Sponsor / Applicant
Vnus Medical Technologies, Inc.

Technical Specification

510(k) Submission ID K052003
Product Code GEI
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4400
Decision Date 2005-10-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40) received FDA 510(k) clearance under submission number K052003, sponsored by Vnus Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-10-11.

Classification & Regulation

This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.