OMNILUX

GUDID B434EM1310

OMNILUX MEDICAL BLUE HEAD

LOTUS GLOBAL GROUP, INC, THE

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: B434EM1310
• NIH Device Record Key: e686dc0c-d15c-44a5-9f01-8b5c09b6b0dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNILUX
• Version Model Number: EM1310
• 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	B434EM1310 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• 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