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

• 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