LightLas 577

GUDID 04712826770642

LIGHTMED CORPORATION

Ophthalmic diode laser system

• Primary Device ID: 04712826770642
• NIH Device Record Key: cef6adb0-25ef-4ddb-9310-13dd814df9f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LightLas 577
• Version Model Number: YC0010
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram
• Weight: 20 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712826770642 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091981

FDA Product Code

• HQF: Laser, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by LIGHTMED CORPORATION

• 04712826770772 - TruScan Pro: 2021-04-21
• 04712826770789 - TruScan Pro: 2021-04-21
• 04712826770796 - TruScan Pro: 2021-04-21
• 04712826770802 - TruScan Pro: 2021-04-21
• 04712826770819 - TruScan Pro: 2021-04-21
• 04712826770826 - TruScan Pro: 2021-04-21
• 04712826770833 - TruScan Pro: 2021-04-21
• 04712826770840 - TruScan Pro: 2021-04-21