FENCER 308 EXCIMER LASER SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K080975
Device Name FENCER 308 EXCIMER LASER SYSTEM
Applicant
KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP
1601 north clancy street
visalia, 
CA 
93291 -9263

Applicant Contact paul y fang
Correspondent
KERA HARVEST/LASER MAX MEDICAL TECHNOLOGIES CORP
1601 north clancy street
visalia, 
CA 
93291 -9263

Correspodent Contact paul y fang
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/07/2008
Decision Date 07/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No