DIOPEXY PROBE


Device Classification Name

laser, ophthalmic

510(k) Number K960522
Device Name DIOPEXY PROBE
Applicant
IRIDERM DIV.
340 pioneer way
mountain view, 
CA 
94041 -1506

Applicant Contact theodore a boutacoff
Correspondent
IRIDERM DIV.
340 pioneer way
mountain view, 
CA 
94041 -1506

Correspodent Contact theodore a boutacoff
Regulation Number 886.4390
Classification Product Code
HQF  
Subsequent Product Codes
GEX   HQB  
Date Received 02/06/1996
Decision Date 07/19/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized