RevoLix and RevoLix Jr.

GUDID 04250341908596

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.

LISA Laser Products GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04250341908596
• NIH Device Record Key: 966851b5-87d3-4456-8185-83c82b217964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoLix and RevoLix Jr.
• Version Model Number: 105 105 331
• Company DUNS: 315026396
• Company Name: LISA Laser Products GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de
• Phone: +49555699380
• Email: service@lisalaser.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250341908596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051167

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-02
• Device Publish Date: 2026-01-23

Devices Manufactured by LISA Laser Products GmbH

• 04250341904413 - Sphinx: 2026-02-02 The Sphinx is a Holmium laser device is a surgical laser system. The laser radiation is solely delivered in pulses. The Sphinx l
• 04250341908596 - RevoLix and RevoLix Jr.: 2026-02-02A 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.
• 04250341908596 - RevoLix and RevoLix Jr.: 2026-02-02 A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/
• 04250341908695 - RevoLix DUO: 2026-02-02 RevoLix DUO is the only universal laser in urology for lithotripsy, BPH, soft tissue surgery, open and laparoscopic surgery. Th
• 04250341910285 - Sphinx Jr.: 2026-02-02
• 04250341910599 - OmniGuide RFID Surgical Fibers: 2026-02-02 LISA Laser Surgical Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic
• 04250341910308 - Sphinx Jr.: 2026-01-23 he Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablatio
• 04250341911695 - RevoLix HTL: 2024-04-12 The RevoLix HTL laser device is a Thulium-YAG laser and emits radiation of the wavelength 2013 nm (±10 nm) (equivalent to appro
• 14250341911579 - FlexGuard: 2018-10-22 Insertion sheath for laser fibres to protect the inner lining of the working channel of an endoskope.