XTRAC

GUDID M709AL100000

Excimer Laser

Strata Skin Sciences, Inc.

Dermatological excimer laser system

• Primary Device ID: M709AL100000
• NIH Device Record Key: 9bd0e2d2-55bb-4bad-b56f-ff8d5db83eef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTRAC
• Version Model Number: AL10000
• Company DUNS: 618522536
• Company Name: Strata Skin Sciences, 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: false
• 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
HIBCC	M709AL100000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073659

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: 2024-05-22
• Device Publish Date: 2024-05-14

On-Brand Devices [XTRAC]

• 010822603: AL 8000 Ultra Plus 7 Series
• 010822602: AL 8000 Ultra Plus
• M709AL100000: Excimer Laser