Search Results
Found 1 results
510(k) Data Aggregation
K Number
K211534Device Name
RevoLix HTL
Manufacturer
Date Cleared
2022-05-19
(366 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LISA Laser Products GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Soft tissue treatments and lithotripsy in the field of urology: In CW mode the indications for use are: Enucleation of the prostate Vaporization of the prostate Opening of ureter and urethral strictures Bladder neck incisions Bladder tumor resections Ureter and kidney tumor ablation Condyloma and penile tumor excision In PULSED mode the indications for use are: Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting
Device Description
The RevoLix HTL is a surgical diode-pumped solid-state laser (DPSS). The laser radiation is generated by the excitation of a solid-state Tm-YAG laser crystal using a QCW laser diode. The laser radiation is cw (continuous wave) or delivered in pulses. The emitted laser radiation has a wavelength of 2.013 nm, which is invisible infrared. RevoLix HTL is a floor standing mobile device. The device is operated by using an operating console equipped with a touch screen and control elements. The laser emission is triggered by a foot switch. The RevoLix HTL operating console enables the user selecting the desired treatment parameters such as laser power and laser energy delivery modes: continuous or pulsed. The GUI is also used to display to the user all operational settings and operational states. The laser is activated by a foot switch. The system design and software ensure that the energy output is delivered as intended by the user. The laser radiation is focused by a fiber coupler into a flexible silica laser fiber which delivers the laser radiation to the surgical site.
Ask a Question
Ask a specific question about this device
Page 1 of 1