Actonis,Hairmax KHXXXYYzzzzzzzz

GUDID 00856823006305

Lower Level Laser Therapy Device K-Kit H-Handheld XXX-Laser Count YY-Product Configuration zzzzzzzz-Logistics and Supply Chain identifiers

Lexington International, LLC

Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device Hair growth laser device

• Primary Device ID: 00856823006305
• NIH Device Record Key: 91fc554b-ae7b-42ea-95ac-423e09c4833d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actonis,Hairmax
• Version Model Number: HXXXYY
• Catalog Number: KHXXXYYzzzzzzzz
• Company DUNS: 104265165
• Company Name: Lexington International, LLC
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856823006305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103368

FDA Product Code

• OAP: Laser, Comb, Hair

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: 2023-12-13
• Device Publish Date: 2023-12-05

Devices Manufactured by Lexington International, LLC

• 00856823006305 - Actonis,Hairmax: 2023-12-13Lower Level Laser Therapy Device K-Kit H-Handheld XXX-Laser Count YY-Product Configuration zzzzzzzz-Logistics and Supply Chain identifiers
• 00856823006305 - Actonis,Hairmax: 2023-12-13 Lower Level Laser Therapy Device K-Kit H-Handheld XXX-Laser Count YY-Product Configuration zzzzzzzz-Logistics and Supply Chain i
• 00856823006046 - HairMax: 2023-05-29 Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00850016973481 - Hairmax: 2022-04-08 Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00850016973047 - HairMax: 2021-12-22 Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006251 - HairMax: 2021-12-22 Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006510 - HairMax: 2021-12-22 Hair Growth Laser Light Device - Low level laser therapy (LLLT)
• 00856823006534 - HairMax: 2021-12-22 Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006732 - HairMax: 2021-12-22 Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)