Pixel CO2 7x7 & 9x9 Applicator for Hybrid System AACO28031927

GUDID 17290110122123

Pixel CO2 7x7 & 9x9 Applicator for Hybrid System

ALMA LASERS LTD.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system

• Primary Device ID: 17290110122123
• NIH Device Record Key: 65de88ac-7af3-4840-b8bd-6a839552db1c
• Commercial Distribution Discontinuation: 2021-07-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pixel CO2 7x7 & 9x9 Applicator for Hybrid System
• Version Model Number: 1
• Catalog Number: AACO28031927
• 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: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290110122123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203441

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: 2021-07-19
• Device Publish Date: 2021-07-11

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