VARAYA AR , VARAYA SPORT


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K112494
Device Name VARAYA AR , VARAYA SPORT
Applicant
VARAYA PHOTOCEUTICALS, LLC
16511 scientific way
suite 200
irvine, 
CA 
92618

Applicant Contact myk lum
Correspondent
VARAYA PHOTOCEUTICALS, LLC
16511 scientific way
suite 200
irvine, 
CA 
92618

Correspodent Contact myk lum
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 08/29/2011
Decision Date 05/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No