LTU-904 FG00002

GUDID 09352877000135

Low Level Laser Therapy Device

MEDICAL MANUFACTURERS PTY LTD

Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use Musculoskeletal/physical therapy laser, home-use

• Primary Device ID: 09352877000135
• NIH Device Record Key: 40e4c7dd-0c94-4142-adfc-d2bf9cbfe5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LTU-904
• Version Model Number: LTU-904
• Catalog Number: FG00002
• Company DUNS: 759484392
• Company Name: MEDICAL MANUFACTURERS PTY LTD
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09352877000135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030295

FDA Product Code

• NZY: Light, Lymphedema Reduction, Low Energy

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: 2023-03-27
• Device Publish Date: 2023-03-17