iHelmet

GUDID 06971008070019

iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifica

Shenzhen Slinph Technology Co., Ltd.

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: 06971008070019
• NIH Device Record Key: 9d8ef527-a5b4-47b6-9447-726803f0462d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iHelmet
• Version Model Number: LTD200S
• Company DUNS: 544372553
• Company Name: Shenzhen Slinph Technology Co., Ltd.
• 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	06971008070019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162782

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-01