EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K112013
Device Name EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
Applicant
BIOLITEC, INC.
1349 main road
granville, 
MA 
01034

Applicant Contact harry hayes
Correspondent
BIOLITEC, INC.
1349 main road
granville, 
MA 
01034

Correspodent Contact harry hayes
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/14/2011
Decision Date 01/13/2012
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