OMNILUX

GUDID B434EM1258S0

OMNILUX MEDICAL BASE

LOTUS GLOBAL GROUP, INC, THE

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional

• Primary Device ID: B434EM1258S0
• NIH Device Record Key: 1545aeca-d853-400b-9969-6263a77039e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNILUX
• Version Model Number: EM1258S
• Company DUNS: 969797406
• Company Name: LOTUS GLOBAL GROUP, INC, THE
• 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
HIBCC	B434EM1258S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030426

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-12-05

On-Brand Devices [OMNILUX]

• B434EM1654: OMNILUX MEDICAL REVIVE2 HEAD
• B434EM1387: OMNILUX MEDICAL PLUS HEAD
• B434EM1310: OMNILUX MEDICAL BLUE HEAD
• B434EM1258S0: OMNILUX MEDICAL BASE