Empower Delivery System

GUDID 00854103007110

Basic Hand Piece (BHP)_600um Fiber Assy (White)

LITECURE LLC

Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous Musculoskeletal/physical therapy laser beam guide, transcutaneous

• Primary Device ID: 00854103007110
• NIH Device Record Key: 50aecff5-f2de-4c7e-8ef5-c3f9fcb5075a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empower Delivery System
• Version Model Number: PRD-000424-010-01-L
• Company DUNS: 858768943
• Company Name: LITECURE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00854103007110 [Primary]

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [Empower Delivery System]

• 00854103007196: Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Dark Gray
• 00854103007189: Legacy Hand Piece 600um Fiber Hand Piece w/ Finger Switch, Cool Gray
• 00854103007172: Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Dark Gray
• 00854103007165: Legacy Hand Piece 800um Fiber Hand Piece w/ Finger Switch, Cool Gray
• 00854103007110: Basic Hand Piece (BHP)_600um Fiber Assy (White)