DIOWAVE LOW LEVEL COLD LASER SYSTEM


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K121363
Device Name DIOWAVE LOW LEVEL COLD LASER SYSTEM
Applicant
TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA)
1209 north flagler drive
west palm beach, 
FL 
33401

Applicant Contact bruce coren
Correspondent
TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA)
1209 north flagler drive
west palm beach, 
FL 
33401

Correspodent Contact bruce coren
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 05/07/2012
Decision Date 11/23/2012
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