Studio

GUDID 08033945934224

QUANTA SYSTEM SPA

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 08033945934224
• NIH Device Record Key: bdf4255d-1520-4245-8703-aa361ec5fd7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Studio
• Version Model Number: PNMS00181
• 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	08033945934224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103539

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: 2021-08-24
• Device Publish Date: 2016-08-18

On-Brand Devices [Studio]

• 08033945934248: PNMS00183
• 08033945934224: PNMS00181