27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA


Device Classification Name

photocoagulator and accessories

510(k) Number K110951
Device Name 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
Applicant
ALCON RESEARCH, LTD.
15800 alton parkway
irvine, 
CA 
92618

Applicant Contact martin a kaufman
Correspondent
ALCON RESEARCH, LTD.
15800 alton parkway
irvine, 
CA 
92618

Correspodent Contact martin a kaufman
Regulation Number 886.4690
Classification Product Code
HQB  
Subsequent Product Codes
HMX   HQE   NGY  
Date Received 04/04/2011
Decision Date 10/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No