FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES


Device Classification Name

powered laser surgical instrument

510(k) Number K022228
Device Name FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
Original Applicant
IRIDEX CORP.
1212 terra bella ave.
mountain view, 
CA 
94043

Original Contact john d’angelo
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/10/2002
Decision Date 10/08/2002
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