ML 830® ML-830-02-000

GUDID 00859626006107

Original Direct Connect

MICROLIGHT CORPORATION OF AMERICA

Musculoskeletal/physical therapy laser, home-use

• Primary Device ID: 00859626006107
• NIH Device Record Key: 3ceb26a1-e422-4672-9025-3890109a2dc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ML 830®
• Version Model Number: ML-830-02-000
• Catalog Number: ML-830-02-000
• Company DUNS: 137829417
• Company Name: MICROLIGHT CORPORATION OF AMERICA
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX
• Phone: 281-433-4648
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859626006107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010175

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: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2016-08-15

On-Brand Devices [ML 830®]

• 00859626006336: Laser Probe Cover
• 00859626006312: SL Triple Probe Holder
• 00859626006299: SL Power Supply
• 00859626006282: SL Console
• 00859626006275: SL Single Probe
• 00859626006268: SL Triple Probe
• 00859626006251: Smart Laser
• 00859626006237: DC Accessory Set
• 00859626006213: DC Console Base
• 00859626006206: DC Console Adapter with Cord
• 00859626006190: DC Console Activation Card
• 00859626006183: New Direct Connect Console
• 00859626006176: Conversion Probe
• 00859626006152: Refurbished Screw-On Adapter
• 00859626006145: Screw-On Adapter - green LED
• 00859626006138: Screw-On Adapter - beeping
• 00859626006114: Small Danger Sign
• 00859626006107: Original Direct Connect
• 00859626006077: Large Danger Sign
• 00859626006053: Safety Glasses
• 00859626006046: Laser Probe
• 00859626006039: Refurbished Battery (rechargeable)
• 00859626006022: Battery (rechargeable)
• 00859626006015: Charging Station
• 00859626006008: Battery Unit
• 00859626006343: Smart Laser DP