IRIDERM, MODEL APEX 800


Device Classification Name

powered laser surgical instrument

510(k) Number K992298
Device Name IRIDERM, MODEL APEX 800
Applicant
IRIDEX CORP.
1212 terra bella ave.
mountain view, 
CA 
94043

Applicant Contact brad renton
Correspondent
IRIDEX CORP.
1212 terra bella ave.
mountain view, 
CA 
94043

Correspodent Contact brad renton
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/08/1999
Decision Date 12/09/1999
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