LITECURE THERAPY SYSTEM


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K103511
Device Name LITECURE THERAPY SYSTEM
Applicant
LITECURE, LLC
250 corporate blvd., suite b
newark, 
DE 
19702

Applicant Contact liang lu
Correspondent
LITECURE, LLC
250 corporate blvd., suite b
newark, 
DE 
19702

Correspodent Contact liang lu
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 11/30/2010
Decision Date 01/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No