RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K110080
Device Name RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
Applicant
BIOLITEC, INC.
515 shaker rd.
east longmeadow, 
MA 
01028

Applicant Contact nancy foley
Correspondent
BIOLITEC, INC.
515 shaker rd.
east longmeadow, 
MA 
01028

Correspodent Contact nancy foley
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/11/2011
Decision Date 02/24/2011
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