FemiLift Sleeve AACO28111922

GUDID 17290110121966

ALMA LASERS LTD.

Multi-modality skin surface treatment system

• Primary Device ID: 17290110121966
• NIH Device Record Key: 98f3362e-0cc7-44af-b418-e418e9a3d3ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemiLift Sleeve
• Version Model Number: 1
• Catalog Number: AACO28111922
• 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	17290110121966 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103501

FDA Product Code

• HQF: Laser, Ophthalmic

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: 2020-12-11
• Device Publish Date: 2020-12-03

On-Brand Devices [FemiLift Sleeve]

• 17290110121980: Package of 24 units
• 17290110121973: Package of 6 units
• 17290110121966: 1
• 17290110121959: 1