PHACOLASE ER: YAG LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K991993
Device Name PHACOLASE ER: YAG LASER
Applicant
AESCULAP-MEDITEC GMBH
2525 mcgaw ave.
irvine, 
CA 
92623 -9791

Applicant Contact william t kelley
Correspondent
AESCULAP-MEDITEC GMBH
2525 mcgaw ave.
irvine, 
CA 
92623 -9791

Correspodent Contact william t kelley
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 06/14/1999
Decision Date 11/17/1999
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