FDA.reportPublic FDA data

RevoLix HTL

Primary DI
04250341911695
Brand
RevoLix HTL
Company
LISA Laser Products GmbH
Model
105 401 010
Device description
The RevoLix HTL laser device is a Thulium-YAG laser and emits radiation of the wavelength 2013 nm (±10 nm) (equivalent to approx. 2 µm). The wavelengths of the laser radiation are in the invisible infrared range. The RevoLix HTL laser device offers a combination of two operating modes. In CW operation (CW), the emission of laser radiation is continuous (continuous wave). In pulsed mode (PULSE or QCW) the radiation is repeatedly emitted at an adjustable frequency. In pulsed mode, the peak power of the individual pulses is higher than the average power
Published
2024-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250341911695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250341911695042503419116954250341911695

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49555699380service@lisalaser.de

Regulatory Flags#

DUNS number
315026396
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250341904413Sphinx103 001 010103 001 0102026-01-23
04250341908596RevoLix and RevoLix Jr.105 105 3312026-01-23
04250341908695RevoLix DUO105 301 111105 301 1112026-01-23
04250341910285Sphinx Jr.101 203 311101 203 3112026-01-23
04250341910599 OmniGuide RFID Surgical Fibers101 503 xxx101 503 6482026-01-23
04250341910308Sphinx Jr. 103 201 1112026-01-15
04250341911572FlexGuard101 503 6312018-09-21
14250341911579FlexGuard101 503 6312018-09-21

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