Pearl Fractional

GUDID 00816722022158

Pearl Fractional Laser Handpiece

CUTERA, INC.

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece

• Primary Device ID: 00816722022158
• NIH Device Record Key: 5694f36d-274f-4724-ab44-4420227d7bb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pearl Fractional
• Version Model Number: Pearl Fractional
• 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
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816722022158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063867

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Pearl Fractional]

• 00816722022158: Pearl Fractional Laser Handpiece
• 00816722022844: Pearl Fractional Laser Handpiece for xeo+/xeo+ SA