FEMTEC LASER SYSTEM FOR CAPSULOTOMY


Device Classification Name

ophthalmic femtosecond laser

510(k) Number K110427
Device Name FEMTEC LASER SYSTEM FOR CAPSULOTOMY
Applicant
TECHNOLAS PERFECT VISION GMBH
po box 17190
anaheim, 
CA 
92817 -7190

Applicant Contact betty m johnson
Correspondent
TECHNOLAS PERFECT VISION GMBH
po box 17190
anaheim, 
CA 
92817 -7190

Correspodent Contact betty m johnson
Regulation Number 886.4390
Classification Product Code
OOE  
Date Received 02/14/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No