RevoLix HTL
Device Facts
| Record ID | K211534 |
|---|---|
| Device Name | RevoLix HTL |
| Applicant | Lisa Laser Products GmbH |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 19, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The RevoLix HTL is a surgical laser intended for non-invasive, and surgically invasive incision, excision, resection, removal, vaporization and coagulation of soft tissue in urology, and for the invasive and surgically invasive destruction of stones in the urogenital tract (bladder, ureter, kidney).
Device Story
RevoLix HTL is a floor-standing, mobile diode-pumped solid-state (DPSS) laser system. It generates 2013 nm infrared laser radiation via a Tm-YAG crystal. Operated by physicians in clinical settings via a touch-screen console and foot switch. Inputs include user-selected treatment parameters (power, energy, mode). The device transforms electrical energy into laser radiation, delivered through a flexible silica fiber to the surgical site. It operates in continuous wave (CW) or pulsed modes. Output is laser energy for soft tissue ablation/coagulation or stone lithotripsy. The GUI displays operational settings and states. The device enables precise tissue removal and stone destruction, potentially reducing retropulsion compared to higher-peak-power Holmium lasers due to higher absorption in water.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including electrical/laser safety (IEC 60601-1, IEC 60825-1), electromagnetic compatibility (IEC 60601-1-2), and software validation (IEC 62304). Biocompatibility of patient-contacting materials was established via predicate device submissions.
Technological Characteristics
Tm:YAG DPSS laser; 2013 nm wavelength; 5-150W power (CW/Pulsed); 5-300 Hz pulse repetition rate; 200-4750 µs pulse duration. Floor-standing mobile form factor with touch-screen GUI. Fiber delivery via silica-silica multimode fiber. Laser safety Class IV (CDRH) / 4 (IEC 60825-1). Applied part Type BF. Input power 110-240V.
Indications for Use
Indicated for soft tissue treatments and lithotripsy in urology. CW mode: enucleation/vaporization of prostate, opening of ureter/urethral strictures, bladder neck incisions, bladder tumor resections, ureter/kidney tumor ablation, condyloma/penile tumor excision. PULSED mode: lithotripsy of bladder, ureter, and kidney stones (fragmentation and dusting).
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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May 19, 2022
LISA Laser Products GmbH Ralf Balkenhol Quality Manager Albert-Einstein-Str, 4 Katlenburg-Lindau Niedersachsen 37191 Germany
Re: K211534
> Trade/Device Name: RevoLix HTL Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 11, 2022 Received: April 18, 2022
Dear Ralf Balkenhol:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K211534
Device Name RevoLix HTL
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary
| General Provisions | |
|------------------------|----------------------------------------------------------------------------------------|
| 510(k) Owners Name: | LISA Laser Products GmbH<br>Albert-Einstein-Str. 4<br>37191 Katlenburg-Lindau, Germany |
| Contact Person: | Dr. Ralf Balkenhol<br>Quality Manager |
| Phone Number: | +49 5556 9938 51 |
| Email: | rbalkenhol@lisalaser.de |
| Fax Number: | +49 5556 9938 10 |
| Classification: | Laser Surgical Instrument for Use in General and Plastic<br>Surgery and in Dermatology |
| Regulation: | 21 CFR § 878.4810 |
| Regulatory Class: | II |
| Proprietary Name: | RevoLix HTL |
| Common Name: | Powered Laser Surgical Instrument |
| Date Summary Prepared: | April 30, 2021 |
# Name of Predicate Device(s)
- Sphinx jr. Holmium Laser (Primary Predicate Device) K132975 ●
- RevoLix 200 (Secondary Predicate Device) K110941 ●
- Lumenis Pulse 120H (Reference Device) K140388 ●
- . Quanta 150W laser, (Reference for pulse mode comparison) - (K201455)
# Intended Use
The RevoLix HTL is a surgical laser intended for non-invasive, and surgically invasive incision, excision, resection, removal, vaporization and coagulation of soft tissue in urology, and for the invasive and surgically invasive destruction of stones in the urogenital tract (bladder, ureter, kidney).
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# Indications for Use
The indications for use of the RevoLix HTL are Soft Tissue treatments and Lithotripsy in the field of urology: In CW mode the indication 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 turnour 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.
# Technological Characteristics
# Substantial Equivalence - Table
Substantial equivalence of RevoLix HTL (Subject Device) is based on the same intended use and similarities in technological characteristics and operation principle with the Sphinx ir. Holmium Laser (Primary Predicate Device) (K132975) and RevoLix 200 (Secondary Predicate Device) (K110941) and which are legally marketed Class II medical devices under 21 CFR 878.4810, i.e., laser surgical instrument for use in general and plastic surgery and in dermatology.
For aspects concerning the higher pulse repetition rate of the RevoLix HTL compared to the predicate devices, the Lumenis Pulse 120H (K140388), and Quanta 150W laser (K201455), for pulse mode comparison which is legally marketed Class II medical devices under 21 CFR 878.4810, i.e., laser surgical instrument for use in general and plastic surgery and in dermatology, is used as a reference device to provide evidence for safety and effectiveness.
NOTE: "Pages 8-9 show an updated table of the comparison of all technical parameters split to tissue and lithotripsy mode. An additional reference device (Quanta Cyber Ho 150W K201455) has been added to the table."
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| Device Name | RevoLix HTL<br>Proposed Device | Sphinx jr.<br>K132975<br>Primary<br>Predicate Device | RevoLix 200<br>K110941<br>Secondary<br>Predicate Device | Lumenis Pulse<br>120H<br>K140388<br>Reference Device | Substantial<br>Equivalence? |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | LISA Laser<br>Products GmbH | LISA Laser<br>Products GmbH | LISA Laser<br>Products GmbH | Lumenis Ltd. | -- |
| Product Code | GEX | GEX | GEX | GEX | Yes, same product<br>code |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Yes, same<br>regulation |
| Device Class | II | II | II | II | Yes, same device<br>class |
| Intended Use | The RevoLix HTL<br>is a surgical laser<br>intended for non-<br>invasive, invasive,<br>and surgically<br>invasive incision,<br>excision, resection,<br>removal,<br>vaporization and<br>coagulation of soft<br>tissue in urology,<br>and for the<br>invasive and<br>surgically invasive<br>destruction of<br>stones in the<br>urogenital tract<br>(bladder, ureter,<br>kidney). | The Sphinx jr.<br>laser system and<br>its fiber optic<br>delivery system are<br>intended for use in<br>surgical<br>procedures using<br>open, laparoscopic<br>and endoscopic<br>incision, excision,<br>resection, ablation,<br>vaporization,<br>coagulation and<br>hemostasis of soft<br>and hard tissue in<br>use in medical<br>specialties<br>including:<br>Urology, Urinary<br>Lithotripsy,<br>Gasteroenterology,<br>Arthroscopy,<br>Discectomy,<br>Pulmonary,<br>Gynecology, ENT,<br>Dermatology,<br>Plastic Surgery and<br>General<br>Surgery | The RevoLix 200<br>laser systems and<br>their fiber optic<br>delivery system<br>are intended for<br>use in surgical<br>procedures using<br>open, laparoscopic<br>and endoscopic<br>incision, excision,<br>resection, ablation,<br>vaporization,<br>coagulation and<br>hemostasis of soft<br>tissue in use in<br>medical specialties<br>including:<br>Urology,<br>Gastroenterology,<br>Thoracic and<br>Pulmonary,<br>Gynecology, ENT,<br>Dermatology,<br>Plastic Surgery,<br>General Surgery.<br>and Arthroscopy | Lumenis Pulse<br>120H is intended<br>for use in surgical<br>procedures<br>involving open,<br>laparoscopic and<br>endoscopic<br>ablation,<br>vaporization,<br>excision, incision,<br>and coagulation of<br>soft tissue in<br>medical specialties<br>including: urology;<br>urinary lithotripsy;<br>arthroscopy;<br>discectomy; ENT.<br>surgery;<br>gynecological<br>surgery;<br>pulmonary<br>surgery;<br>gastroenterology<br>surgery;<br>dermatology and<br>plastic surgery and<br>general surgery. | Yes, same intended<br>use with the<br>primary predicate<br>device.<br>Large degree of<br>overlap with the<br>secondary<br>predicate |
| Indications<br>for use | Soft tissue<br>treatments and<br>lithotripsy in the<br>field of urology:<br><br>• Enucleation of<br>the prostate<br>• Vaporization<br>of the prostate<br>• Opening of<br>ureter and | - Urology<br><br>Open and<br>endoscopic surgery<br>(incision, excision,<br>resection, ablation,<br>vaporization,<br>coagulation and<br>hemostasis)<br>including: | - Urology<br><br>Open and<br>endoscopic surgery<br>(incision, excision,<br>resection, ablation,<br>vaporization,<br>coagulation and<br>hemostasis)<br>including: | - Urology<br><br>Endoscopic<br>transurethral<br>incision of the<br>prostate (TUWP),<br>bladder neck<br>incision of the<br>prostate (BNI),<br>holmium laser<br>ablation of the<br>prostate (HoLAP), | Yes, equivalent<br>The RevoLix HTL<br>has the same<br>indications in<br>urology. Predicate<br>devices have<br>additional<br>indication in other<br>fields |
| Device Name | RevoLix HTL<br>Proposed Device | Sphinx jr.<br>K132975<br>Primary<br>Predicate Device | RevoLix 200<br>K110941<br>Secondary<br>Predicate Device | Lumenis Pulse<br>120H<br>K140388<br>Reference Device | Substantial<br>Equivalence? |
| | urethral strictures Bladder neck incisions Bladder tumor resections Ureter and kidney tumor ablation Condyloma and penile tumor excision Lithotripsy of bladder, ureter and kidney stones including fragmentation and dusting | Urethral Strictures<br>Bladder Neck Incisions<br>Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors.<br>Ablation of Benign Prostatic Hypertrophy (BHP)<br>Resection of the Prostate<br>Condylomas<br>Lesions of external genitalia<br>Lithotripsy and Percutaneous Urinary Lithotripsy<br>Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi<br>Endoscopic fragmentation of kidney calculi<br>Treatment of steinstrasse when guide wire cannot be passed<br>Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic surgery, General Surgery,<br>Arthroscopy | Urethral Strictures<br>Bladder Neck Incisions (BNI)<br>Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors.<br>Ablation of Benign Prostatic Hypertrophy (BHP),<br>Transurethral incision of the prostate (TUIP)<br>Laser Resection of the Prostate (HoLRP)<br>Laser Enucleation of the Prostate (HoLEP)<br>Laser Ablation of the Prostate (HoLAP)<br>Condylomas<br>Lesions of external genitalia<br>Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic surgery, General Surgery, Arthroscopy | enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of. bladder; superficial and invasive bladder, urethral and ureteral tumors; condylomas; lesions of external genitalia; ureteral and penile haemangioma; ureteral strictures; bladder neck obstructions Urinary Lithotripsy including:<br>endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, | |
| Device Name | RevoLix HTL<br>Proposed Device | Sphinx jr.<br>K132975<br>Primary<br>Predicate Device | RevoLix 200<br>K110941<br>Secondary<br>Predicate Device | Lumenis Pulse<br>120H<br>K140388<br>Reference Device | Substantial<br>Equivalence? |
| | | | | including cystine,<br>calcium oxalate,<br>monohydrate and<br>calcium oxalate<br>dihydrate stones;<br>treatment of distal<br>impacted<br>fragments of<br>steinstrasse when<br>guide wires cannot<br>be passed. | |
| | | | | Arthroscopy,<br>General Surgery,<br>ENT Surgery,<br>Gynecological<br>Surgery,<br>Gastroenterology<br>Surgery,<br>Pulmonary<br>Surgery,<br>Dermatology and<br>Plastic Surgery | |
| Laser type | Tm:YAG Diode<br>Pumped Solid<br>State laser | -- | Tm:YAG Diode<br>Pumped Solid<br>State laser | | Yes, same laser<br>type |
| | -- | HoYAG flash lamp<br>pumped solid state<br>laser | -- | HoYAG flash lamp<br>pumped solid state<br>laser | |
| Wavelength | Tm:YAG 2013 nm<br>(±10 nm) | -- | 2.01 μm | | Yes, same<br>wavelength |
| | -- | 2123 nm (± 3 nm) | -- | 2.1 μm | Equivalent, the<br>difference in<br>wavelengths has<br>been shown in<br>V&V tests to have<br>negligible effect on<br>safety and<br>performance. |
| CW mode | Power: 5 - 150W<br>RevoLix HTL eco:<br>5 - 75 W | -- | Power: max 200W | | Equivalent, higher<br>power in CW<br>mode.<br>Same / lower<br>power compared to<br>reference device |
| Pulse mode | Average power:<br>5 - 150W | Average power:<br>max. 30W | Average Power:<br>max. 200W | Average Power:<br>max 120W | Equivalent, the<br>average power in<br>Pulsed mode for |
| Device Name | RevoLix HTL<br>Proposed Device | Sphinx jr.<br>K132975<br>Primary<br>Predicate Device | RevoLix 200<br>K110941<br>Secondary<br>Predicate Device | Lumenis Pulse<br>120H<br>K140388<br>Reference Device | Substantial<br>Equivalence? |
| | RevoLix HTL eco:<br>5 - 75 W | | | | RevoLix HTL<br>exceeds that of the<br>Sphinx jr. This<br>represents a<br>technical<br>advancement and<br>is unlikely to affect<br>safety and<br>performance of the<br>RevoLix HTL. |
| | Pulse peak power:<br>max. 1.3 kW | Pulse peak power:<br>max. 18 kW | Pulse peak power:<br>max. 200W | unknown | The RevoLix HTL<br>has a lower pulse<br>peak power. |
| | Pulse energy:<br>0.3 - 4.5 J | Pulse energy:<br>0.3 - 3.5 J | n/a | 0.2 - 6 J | The RevoLix HTL<br>is capable of<br>achieving a pulse<br>energy in the same<br>range as in the<br>equivalent devices. |
| | Pulse repetition<br>rate:<br>5 - 300 Hz | Pulse repetition<br>rate:<br>1 - 20 Hz | Pulse repetition<br>rate:<br>0.5 - 10 Hz | Pulse repetition<br>rate:<br>5 - 80 Hz | The RevoLix HTL<br>is capable of<br>achieving a pulse<br>repetition rate in<br>the same range as<br>in the equivalent<br>devices. |
| | Pulse duration:<br>200 - 4750 µs | Pulse duration:<br>max. 650 µs | Pulse duration:<br>50 - 1000 ms | Pulse duration:<br>short / mid / long<br>max 1300 µs | The RevoLix HTL<br>is capable of<br>achieving a pulse<br>duration in the<br>same range as in<br>the equivalent<br>devices. |
| Aiming beam | Wavelength:<br>532 nm (green) | Wavelength:<br>635 nm (red)<br>or 532 nm (green) | Wavelength:<br>635 nm (red) | Wavelength:<br>532 nm (green) | Yes, equivalent.<br>RevoLix HTL only<br>offers a 532 nm<br>beam, the other<br>devices also offer a<br>635 nm beam. The<br>wavelength of the<br>aiming beam has<br>negligible effect on<br>safety and<br>performance. |
| | Power: 1 - 3 mW | Power: max. 5<br>mW | Power: max. 1<br>mW, | Power: max. 5<br>mW, | Yes, similar.<br>The power of the<br>aiming beam<br>offered by<br>RevoLix HTL lies |
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| Device Name | RevoLix HTL<br>Proposed Device | Sphinx jr.<br>K132975<br>Primary<br>Predicate Device | RevoLix 200<br>K110941<br>Secondary<br>Predicate Device | Lumenis Pulse<br>120H<br>K140388<br>Reference Device | Substantial<br>Equivalence? |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Laser Class | 4 (IEC 60825-1)<br>IV (CDRH) | 4 (IEC 60825-1) | 4 (IEC 60825-1) | 4 (IEC 60825-1)<br>IV (CDRH) | Yes, identical |
| Applied part | Type (IEC 60601-1): BF | Type (IEC 60601-1): BF | Type (IEC 60601-1): BF | Type (IEC 60601-1): BF | Yes, identical…
