NIR Module AAIR02031605

GUDID 17290110121676

ALMA LASERS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 17290110121676
• NIH Device Record Key: 379fdb74-54b6-4228-acde-91e8f62a28ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIR Module
• Version Model Number: 1
• Catalog Number: AAIR02031605
• Company DUNS: 532283264
• Company Name: ALMA LASERS LTD.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290110121676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172193

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2019-01-14
• Device Publish Date: 2018-12-13

On-Brand Devices [NIR Module ]

• 17290110121676: 1
• 17290110121669: 1