Q-plus A

GUDID 08033945934187

QUANTA SYSTEM SPA

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 08033945934187
• NIH Device Record Key: 150e25db-b7f0-44cc-b6c3-b7b7bc1e12e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-plus A
• Version Model Number: PCMS00323
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM SPA
• 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	08033945934187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160368

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: 2019-09-30
• Device Publish Date: 2016-08-18

On-Brand Devices [Q-plus A ]

• 08033945934187: PCMS00323
• 08033945933807: PNMS00169