FEMTO LDV


Device Classification Name

laser, ophthalmic

510(k) Number K112154
Device Name FEMTO LDV
Applicant
SIE AG,SURGICAL INSTUMENT ENGINEERING
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Applicant Contact kevin walls
Correspondent
SIE AG,SURGICAL INSTUMENT ENGINEERING
5401 s. cottonwood ct.
greenwood village, 
CO 
80121

Correspodent Contact kevin walls
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 07/27/2011
Decision Date 03/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls