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510(k) Data Aggregation
K Number
K131207Device Name
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
Manufacturer
SURGICAL INSTRUMENT ENGINEERING AG
Date Cleared
2013-10-09
(163 days)
Product Code
HQF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL INSTRUMENT ENGINEERING AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the comea at a varying depth with respect to the corneal surface.
In addition, the FEMTO LDV Z6 Surgical Laser is intended for use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
Device Description
Corneal dissection with the FEMTO LDV Z6 Femtosecond Surgical Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical pulses which are delivered through an applanation window assembly while fixating the eye under a vacuum.
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