(256 days)
The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface.
In addition, the FEMTO LDVIM Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
The design of the FEMTO LDV™ Z8 is based on the FDA cleared FEMTO LDV™ Z Models Femtosecond Surgical Lasers Z2-Z6. The application of femtosecond lasers in the field of cataract surgery was achieved with extended focusing capabilities and improved visualization based on existing technologies. The FEMTO LDV™ Z8 Femtosecond Surgical Laser uses smaller spots with lower pulse energies at higher repetition rates to achieve tissue dissection.
The provided document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification letter, a 510(k) summary, and an indications for use statement for the FEMTO LDV™ Z8 Femtosecond Surgical Laser.
The sections that would typically contain such information (like "Acceptance Criteria," "Device Performance," or details of a clinical study) are absent. Instead, the document focuses on:
- Substantial equivalence: Comparing the new device to predicate devices (Ziemer LDV™ Z6 and Optimedica® Catalys™ Precision Laser System) based on technological characteristics and safety profiles.
- Nonclinical tests: Mentioning sterilization validation, shelf-life testing, biocompatibility testing, safety tests (IEC 60601-1, IEC 60601-1-2, IEC 60825), design validation (including in-vitro performance testing), and software validation. These are general and do not specify performance metrics or acceptance criteria for the intended use.
- Intended Use/Indications for Use: Describing the surgical applications of the laser.
Therefore, it is not possible to complete the requested table or answer the questions based on the provided text. The document states that "The FEMTO LDV™ Z8 Femtosecond Surgical Laser was found to perform equivalently to the predicate devices to achieve tissue dissection for corneal flap, rings, pockets, keratoplasty, corneal and arcuate incisions, capsulotomy, and lens fragmentation." This is a general statement of equivalence rather than a detailed report of specific performance criteria and a study demonstrating their achievement.
The document emphasizes that no new issues of safety and effectiveness arise compared to the predicate devices due to similar underlying physical processes and comparable performance profiles.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.