RevoLix HTL

Lisa Laser Products GmbH

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K211534
Device name
RevoLix HTL
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-05-18
Decision date
2022-05-19
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for 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

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.

Summary parsed at:2026-06-01 05:38:11 UTC

Predicate devices

4

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0

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