Laser Speckle Flowgraphy LSFG-NAVI

GUDID 04589662680028

SOFTCARE CO., LTD.

Scanning-laser ophthalmic imaging system

• Primary Device ID: 04589662680028
• NIH Device Record Key: 70d09bf1-306a-4de6-af89-943c7a2d5ad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Speckle Flowgraphy LSFG-NAVI
• Version Model Number: LSFG-NAVI-NM2
• Company DUNS: 711448795
• Company Name: SOFTCARE CO., LTD.
• 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: false
• 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	04589662680028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153239

FDA Product Code

• HLI: Ophthalmoscope, Ac-Powered

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: 2018-07-06
• Device Publish Date: 2018-02-19

On-Brand Devices [Laser Speckle Flowgraphy LSFG-NAVI]

• 04589662680028: LSFG-NAVI-NM2
• 04589662680035: LSFG-NAVI-NM2