Handpiece 515 (6.4) for Harmony XL 50000 pulses AAHP01050805

GUDID 17290110120396

ALMA LASERS LTD.

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

• Primary Device ID: 17290110120396
• NIH Device Record Key: 3068e81b-b7ff-4336-9dd2-509cac068e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handpiece 515 (6.4) for Harmony XL 50000 pulses
• Version Model Number: 1
• Catalog Number: AAHP01050805
• 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: true
• 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	17290110120396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072564

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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

Devices Manufactured by ALMA LASERS LTD.

• 17290110123526 - Diode 755nm Alex Applicator for Soprano Titanium (Black): 2024-03-25 Diode 755nm Alex Applicator for Soprano Titanium (Black)
• 07290110123451 - ClearVas: 2024-02-26
• 07290110123468 - ClearLift: 2024-02-26
• 07290110123475 - Alma SupErb: 2024-02-26
• 07290110123482 - ClearSkin: 2024-02-26
• 07290110123444 - NIR Face (6) HP: 2024-02-07
• 07290110123406 - Iris SR IPL HP: 2024-02-06
• 07290110123413 - Iris VL/PL IPL HP: 2024-02-06