LenSx Laser System (8065998162)

The LenSx Laser System is an ophthalmic surgical laser that uses focused femtosecond laser pulses to create precise cuts and separations in eye tissue (photodisruption). It is indicated for use in cataract surgery (corneal incisions, anterior capsulotomy, lens fragmentation), ICL surgery, LASIK flap creation, and corneal pocket/tunnel creation for inlay and ring placement.

The subject device (version 2.40) is identical to the predicate in core specifications: 1030 nm Kb:KYW laser, 600-800 fs pulse duration, 50 kHz repetition rate for cataract/ICL procedures, same power levels and surgical depths. The main differences are software enhancements including an embedded arcuate nomogram calculator, additional phacofragmentation cut patterns (horizontal, thick cross, star), capsulorhexis markers for toric IOL alignment, and a new corneal incision setting for ICL procedures.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-4-2 (electrical/EMC safety); ANSI Z80.36-2021 (optical radiation safety); ISO 10993-1 (biocompatibility); ISO 14971 (risk management); FDA guidance on software verification and validation (June 2023) and cybersecurity (September 2023).

The subject device shares identical system design, architecture, materials, patient interface accessories, and indications for use as the predicate. All technological characteristics affecting clinical performance—laser wavelength, pulse parameters, imaging modalities, and surgical capabilities—are the same. The software modifications introduce minor features that do not adversely affect safety or effectiveness; bench testing and software validation demonstrated these new features function as intended without raising new safety or efficacy questions. Risk profiles are equivalent, and no animal or clinical testing was required because the risk assessment identified no new hazards.