EPIC 10


Device Classification Name

powered laser surgical instrument

510(k) Number K121286
Device Name EPIC 10
Applicant
BIOLASE TECHNOLOGY, INC.
4 cromwell
irvine, 
CA 
92618 -1816

Applicant Contact robert yang
Correspondent
BIOLASE TECHNOLOGY, INC.
4 cromwell
irvine, 
CA 
92618 -1816

Correspodent Contact robert yang
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received 04/30/2012
Decision Date 09/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No