TruScan Pro

GUDID 04712826770987

LIGHTMED CORPORATION

Ophthalmic solid-state laser system, photocoagulation/photostimulation

• Primary Device ID: 04712826770987
• NIH Device Record Key: aaad527e-6438-4ddd-94c5-cdad1f2d7e19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruScan Pro
• Version Model Number: TP0016
• Company DUNS: 657731175
• Company Name: LIGHTMED CORPORATION
• 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: true
• 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
GS1	04712826770987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190448

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-16
• Device Publish Date: 2020-04-08

On-Brand Devices [TruScan Pro]

• 04712826771007: TP0022
• 04712826770994: TP0021
• 04712826770987: TP0016
• 04712826770970: TP0013
• 04712826770888: TP0012
• 04712826770871: TP0011
• 04712826770864: TP0010
• 04712826770857: TP0009
• 04712826770840: TP0008
• 04712826770833: TP0007
• 04712826770826: TP0006
• 04712826770819: TP0005
• 04712826770802: TP0004
• 04712826770796: TP0003
• 04712826770789: TP0002
• 04712826770772: TP0001 (532/577/670/810)