Dermastat

GUDID 08167222022349

Dermastat 2mm Handpiece for EV+

CUTERA, INC.

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 08167222022349
• NIH Device Record Key: ac5d3647-63cb-4e02-b23e-92d94a0a6385
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermastat
• Version Model Number: Dermastat 2mm
• Company DUNS: 041071643
• Company Name: CUTERA, 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

Customer Support Contacts

• Phone: 1 415 657-5500
• Email: info@cutera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08167222022349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132185

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [Dermastat]

• 08167222022349: Dermastat 2mm Handpiece for EV+
• 00816722022349: Dermastat 2mm Handpiece for EV+