INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K030181
Device Name INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
Original Applicant
INTERNATIONAL BIOPHYSICS CORP.
4020 south industrial dr.
suite 160
austin, 
TX 
78744

Original Contact len hickey
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/17/2003
Decision Date 04/17/2003
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