RevoLix DUO 105 301 111

GUDID 04250341908695

RevoLix DUO is the only universal laser in urology for lithotripsy, BPH, soft tissue surgery, open and laparoscopic surgery. This versatility is achieved by combining a pulsed Holmium and a 2micron continuous wave (cw) laser in a single box

LISA Laser Products GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04250341908695
• NIH Device Record Key: 6ad9eebd-71c1-48bc-b5ec-ef07e7c6b785
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoLix DUO
• Version Model Number: 105 301 111
• Catalog Number: 105 301 111
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250341908695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070466

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.: 2026-02-02 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. This versatility is achieved by combining a pulsed Holmium and a 2micron continuous wave (cw) laser in a single box
• 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.