Sphinx Jr. 101 203 311

GUDID 04250341910285

LISA Laser Products GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04250341910285
• NIH Device Record Key: 9c535f0f-f7e7-4227-8361-1c7d42562e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sphinx Jr.
• Version Model Number: 101 203 311
• Catalog Number: 101 203 311
• 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: 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	04250341910285 [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: 2026-02-02
• Device Publish Date: 2026-01-23

On-Brand Devices [Sphinx Jr.]

• 04250341910308: he Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The pur
• 04250341910285: 101 203 311