SCULPTURE 2.94 ER:YAG SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K073158
Device Name SCULPTURE 2.94 ER:YAG SYSTEM
Applicant
HOYA CONBIO, INC
19722 westview drive
twain harte, 
CA 
95383

Applicant Contact liza burns
Correspondent
HOYA CONBIO, INC
19722 westview drive
twain harte, 
CA 
95383

Correspodent Contact liza burns
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/08/2007
Decision Date 08/27/2008
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