Regenalase

GUDID 00810071230516

Regenalase Therapy Kit, Regenalase Photobiomodulation (PBM) Kit

IPG Medical Corporation

General/multiple surgical diode laser system

• Primary Device ID: 00810071230516
• NIH Device Record Key: 6e769626-1a8a-414b-9ceb-2a23bedf9667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regenalase
• Version Model Number: MD2300F-001518
• Company DUNS: 081504133
• Company Name: IPG Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00810071230516 [Primary]

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: 2025-06-17
• Device Publish Date: 2025-06-09

On-Brand Devices [Regenalase]

• 00810071230592: Attachment Head D
• 00810071230585: Attachment Head B2
• 00810071230578: Attachment Head C
• 00810071230554: Attachment Head B1
• 00810071230547: Universal Stage One Handpiece
• 00810071230530: Laser System
• 00810071230523: Wired Footswitch
• 00810071230516: Regenalase Therapy Kit, Regenalase Photobiomodulation (PBM) Kit
• 00810071230509: Laser System