FEMTO LDV

Laser, Ophthalmic

SIE AG,SURGICAL INSTUMENT ENGINEERING

The following data is part of a premarket notification filed by Sie Ag,surgical Instument Engineering with the FDA for Femto Ldv.

Pre-market Notification Details

• Device ID: K112154
• 510k Number: K112154
• Device Name: FEMTO LDV
• Classification: Laser, Ophthalmic
• Applicant: SIE AG,SURGICAL INSTUMENT ENGINEERING 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121
• Contact: Kevin Walls
• Correspondent: Kevin Walls; SIE AG,SURGICAL INSTUMENT ENGINEERING 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121
• Product Code: HQF
• CFR Regulation Number: 886.4390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-27
• Decision Date: 2012-03-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640167750856	K112154	000
07640167750979	K112154	000
07640167750962	K112154	000
07640167750412	K112154	000
07640167750948	K112154	000
07640167750931	K112154	000
07640167750382	K112154	000
07640167750375	K112154	000
07640167750368	K112154	000
07640167750047	K112154	000
07640167750030	K112154	000
07640167750986	K112154	000
07640167750450	K112154	000
07640167751006	K112154	000
07640167750849	K112154	000
07640167750832	K112154	000
07640167750825	K112154	000
07640167750818	K112154	000
07640167750801	K112154	000
07640167750795	K112154	000
07640167751044	K112154	000
07640167751037	K112154	000
07640167751020	K112154	000
07640167751013	K112154	000
07640167750023	K112154	000