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LISA LASER PRODUCTS GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30031681013003168101LISA LASER PRODUCTS GMBH1N2026-01-01ALBERT-EINSTEIN-STR. 4 KATLENBURG-LINDAU Lower Saxony DE 37191

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04250341904413Sphinx - The Sphinx is a Holmium laser device is a surgical laser system. The laser radiation is solely delivered in pulses. The Sphinx laser has the wavelength 2123 nm (± 3 nm) - equal to 2.1 micron, which is invisible infrared. The laser radiation is focused by a fiber coupler into a flexible silica laser fiber which delivers the laser radiation to the surgical site. The laser system is operated from an operating panel with a display and control elements. The laser is activated by a foot switch.+49555699380service@lisalaser.de
04250341908596RevoLix and RevoLix Jr. - A 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 hemostasis, 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.+49555699380service@lisalaser.de
04250341911572FlexGuard - Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.+49555699380info@lisalaser.de
04250341911695RevoLix HTL - 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+49555699380service@lisalaser.de

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3009982042114054K211534RevoLix HTLGEX2022-05-19
3009981094990351K132975SPHINX JRGEX2014-03-18
3009981394780426K110941REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200GEX2013-02-19
3009981412800040K070924FLEXGUARDGEX2007-06-21
3009981820459171K070476REVOLIX 120GEX2007-03-26
3009981269046359K070466REVOLIX DUO LASER SYSTEMGEX2007-04-17
3009981551092255K051167REVOLIX AND REVOLIX JRGEX2005-06-01
3009981576478725K033437SPHINX LASER SYSTEMSGEX2004-01-20
3009981795203360K033423REVOLIX LASER SYSTEMSGEX2004-01-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX92022-05-19

PMN#

GUDID#