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

• 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)