AYON Body Contouring System

GUDID 00607151050993

APYX MEDICAL CORPORATION

Liposuction system

• Primary Device ID: 00607151050993
• NIH Device Record Key: 03c0165b-573d-43c7-8d2f-fe0aa9b9562a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AYON Body Contouring System
• Version Model Number: AYON
• Company DUNS: 101223287
• Company Name: APYX MEDICAL CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607151050993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K244050

FDA Product Code

• QPB: System, Suction, Lipoplasty For Removal

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: 2025-06-06
• Device Publish Date: 2025-05-29

Devices Manufactured by APYX MEDICAL CORPORATION

• 00607151050504 - AYON Console: 2025-06-11
• 00607151050481 - AYON Wireless Footswitch: 2025-06-06 Wireless Footswitch
• 00607151050498 - AYON Base Tower: 2025-06-06
• 00607151050511 - AYON Base Tower: 2025-06-06
• 00607151050528 - AYON Infiltration Handle: 2025-06-06
• 00607151050535 - AYON Infiltration Handle on/off: 2025-06-06
• 00607151050559 - AYON Ultrasound Assisted Liposuction Handpiece: 2025-06-06
• 00607151050566 - AYON Ultrasound Assisted Liposuction Cable: 2025-06-06