HairMax 856823006510

GUDID 00856823006510

Hair Growth Laser Light Device - Low level laser therapy (LLLT)

LEXINGTON INTERNATIONAL, LLC

Hair growth laser device

• Primary Device ID: 00856823006510
• NIH Device Record Key: 1fc20f3b-ee2f-4cd3-b44a-5846026cbf5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HairMax
• Version Model Number: LaserBand 41
• Catalog Number: 856823006510
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856823006510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142573

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: 2021-12-22
• Device Publish Date: 2021-12-10

On-Brand Devices [HairMax]

• 00856823006152: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006145: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006138: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006008: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006725: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006718: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006701: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006619: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00850016973078: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006732: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006534: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006510: Hair Growth Laser Light Device - Low level laser therapy (LLLT)
• 00856823006251: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00850016973047: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00850016973481: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
• 00856823006046: Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)