Sphinx Jr.

GUDID 04250341910308

he Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device

LISA Laser Products GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04250341910308
• NIH Device Record Key: 76312bd8-c351-4fe1-a909-f27008c4b0e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sphinx Jr.
• Version Model Number: 103 201 111
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250341910308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132975

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: 2026-01-23
• Device Publish Date: 2026-01-15

Devices Manufactured by LISA Laser Products GmbH

• 04250341910308 - Sphinx Jr.: 2026-01-23he Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device
• 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.