enlighten

GUDID 00816722023605

enlighten Micro Lens Array handpiece attachment

CUTERA, INC.

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 00816722023605
• NIH Device Record Key: 1f307339-2f7e-4606-8114-a2b060cd2f64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enlighten
• Version Model Number: Micro Lens Array
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816722023605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182997

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: 2019-02-14
• Device Publish Date: 2019-01-14

On-Brand Devices [enlighten]

• 00816722023605: enlighten Micro Lens Array handpiece attachment
• 00816722021649: enlighten III Laser System
• 00816722021625: enlighten SR Laser System
• 00816722021618: enlighten Low Energy Green Laser System
• 00816722021601: enlighten Laser System