1064+ Handpiece

GUDID 00841494100261

1064+ Handpiece

Cynosure, Inc.

Multi-modality skin surface treatment system

• Primary Device ID: 00841494100261
• NIH Device Record Key: 07b6ad62-e77d-4659-8b67-1ecc9f9a086e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1064+ Handpiece
• Version Model Number: 2520A-1064P
• Company DUNS: 780318028
• Company Name: Cynosure, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494100261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110907

FDA Product Code

• ONG: Powered laser surgical instrument with microbeam\fractional output

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: 2016-09-24

On-Brand Devices [1064+ Handpiece]

• 00841494100674: 1064+ Handpiece Remanufactured
• 00841494100261: 1064+ Handpiece