Pearl

GUDID 00816722022141

Pearl Laser Handpiece

CUTERA, INC.

Laser skin surface treatment system applicator

• Primary Device ID: 00816722022141
• NIH Device Record Key: da67d001-dfee-4423-8ca7-a6c3bb56e549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pearl
• Version Model Number: Pearl
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816722022141 [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

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• 00816722022820 - Prowave: 2022-12-08 Prowave IPL Handpiece for xeo+/xeo+ SA
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• 00816722022844 - Pearl Fractional: 2022-12-08 Pearl Fractional Laser Handpiece for xeo+/xeo+ SA
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