VELscope 4660

GUDID 07540201000094

LED Dental Inc

Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light Oral lesion examination light

• Primary Device ID: 07540201000094
• NIH Device Record Key: ac0045e0-ef61-40ef-ba2f-32819740da25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VELscope
• Version Model Number: VELscope Vx Value Bundle-Basic
• Catalog Number: 4660
• Company DUNS: 243167546
• Company Name: LED Dental 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: true
• 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
GS1	07540201000094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102083

FDA Product Code

• NXV: Diagnostic Light, Soft Tissue Detector

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: 2019-12-06
• Device Publish Date: 2016-12-21

On-Brand Devices [VELscope]

• 00754020100096: VELscope Vx Value Bundle-Basic
• 00754020100041: VELscope Vx Value Bundle-US
• 00754020100010: VELscope Vx
• 07540201000094: VELscope Vx Value Bundle-Basic
• 07540201000049: VELscope Vx Value Bundle-US
• 27540201000036: VELsheath Vx
• 07540201000025: VELcap Vx
• 07540201000018: VELscope Vx