INFINI RADIOFREQUENCY SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K121481
Device Name INFINI RADIOFREQUENCY SYSTEM
Applicant
LUTRONIC CORPORATION
6 neshaminy interplex,
suite 207
trevose, 
PA 
19053

Applicant Contact jhung won vojir
Correspondent
LUTRONIC CORPORATION
6 neshaminy interplex,
suite 207
trevose, 
PA 
19053

Correspodent Contact jhung won vojir
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 05/18/2012
Decision Date 06/25/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No