Large Sapphire Optic

GUDID 00841494100155

Vectus Large Sapphire Optic

Cynosure, Inc.

Dermatological Raman spectroscopy system

• Primary Device ID: 00841494100155
• NIH Device Record Key: 7d594c58-c1b4-49f7-a138-b1c0b02dcdc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Sapphire Optic
• Version Model Number: 3520C-0002
• Company DUNS: 780318028
• Company Name: Cynosure, 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: false
• 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	00841494100155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120622

FDA Product Code

• GEX: Powered laser surgical instrument

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: 2018-12-21
• Device Publish Date: 2016-09-24

On-Brand Devices [Large Sapphire Optic]

• 00841494100162: Vectus Large Sapphire Optic Refurbished
• 00841494100155: Vectus Large Sapphire Optic