LEP 2000 Photonic Therapy System

GUDID B420LEP2000100A0

IMI Healing Technologies Inc

Blue/red/infrared phototherapy lamp

• Primary Device ID: B420LEP2000100A0
• NIH Device Record Key: 756d406b-62ef-4a03-9f1b-df93c485a3a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEP 2000 Photonic Therapy System
• Version Model Number: LEP2000100A
• Company DUNS: 248483948
• Company Name: IMI Healing Technologies Inc
• 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
HIBCC	B420LEP2000100A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073689

FDA Product Code

• NHN: Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22

On-Brand Devices [LEP 2000 Photonic Therapy System]

• B420LEP2000PTS0: 1
• B420LEP2000100D0: LEP2000100D
• B420LEP2000100C0: LEP2000100C
• B420LEP2000100B0: LEP2000100B
• B420LEP2000100A0: LEP2000100A
• B420LD1000: LD100