Manufacturer
Lisa Laser Products GmbHRevoLix HTL
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K211534
- Device name
- RevoLix HTL
- Company
- Lisa Laser Products GmbH
- 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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Not ingested
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Not ingested
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Not ingested
Litho 150, Cyber Ho 150
K211534 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K211534 as a predicate
