iGrow Hair Growth System

GUDID 20861134000106

iGrow Hair Growth System, Standard Single Unit

APIRA SCIENCE, INC.

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