GWODE Laser Hair Growth Cap

GUDID D549215

Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of laser diodes.

BLISSCO MEDICAL DEVICE LIMITED

Hair growth laser device

• Primary Device ID: D549215
• NIH Device Record Key: b7b17ee7-b425-4072-b3b7-8ae67c706b00
• Commercial Distribution Discontinuation: 2026-05-14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GWODE Laser Hair Growth Cap
• Version Model Number: 1.0
• Company DUNS: 989184851
• Company Name: BLISSCO MEDICAL DEVICE LIMITED
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D549215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192627

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: 2024-11-25
• Device Publish Date: 2024-11-16

On-Brand Devices [GWODE Laser Hair Growth Cap]

• D549215: Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote
• G680D549215: Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote