IRIDIS OPHTHALMIC PHOTOCOAGULATOR


Device Classification Name

laser, ophthalmic

510(k) Number K023094
Device Name IRIDIS OPHTHALMIC PHOTOCOAGULATOR
Original Applicant
QUANTEL MEDICAL
342 sunset bay rd.
hot springs, 
AR 
71913

Original Contact roger w barnes
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 09/18/2002
Decision Date 12/17/2002
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