iGrow Hair Growth System

GUDID 20861134000106

iGrow Hair Growth System, Standard Single Unit

APIRA SCIENCE, INC.

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

• Primary Device ID: 20861134000106
• NIH Device Record Key: f76fb457-86f1-4727-9483-af6fff0b6bd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iGrow Hair Growth System
• Version Model Number: PE104IG00
• Company DUNS: 010514721
• Company Name: APIRA SCIENCE, INC.
• 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: false
• Manufacturing Date: false
• 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: false

Customer Support Contacts

• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com
• Phone: (561)465-7000
• Email: ray@apirascience.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861134000102 [Primary]
GS1	10861134000109 [Package]; Contains: 00861134000102; Package: Master Carton [6 Units]
GS1	20861134000106 [Package]; Contains: 00861134000102; Package: 2-pack [2 Units]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122248

FDA Product Code

• OAP: Laser, Comb, Hair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-28