VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551


Device Classification Name

unit, phacofragmentation

510(k) Number K080803
Device Name VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
Applicant
AMERICAN OPTISURGICAL, INC.
25501 arctic ocean
lake forest, 
CA 
92630

Applicant Contact david salzberg
Correspondent
AMERICAN OPTISURGICAL, INC.
25501 arctic ocean
lake forest, 
CA 
92630

Correspodent Contact david salzberg
Regulation Number 886.4670
Classification Product Code
HQC  
Subsequent Product Code
NKX  
Date Received 03/21/2008
Decision Date 09/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No