Hand-held IPL device (IPL Home Use Hair Removal Device)

GUDID 06973071101003

IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Shenzhen IONKA Medical Technology Co., Ltd.

Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit Home-use intense pulsed light hair removal unit

• Primary Device ID: 06973071101003
• NIH Device Record Key: 4ee3543f-2809-4f17-8111-b0a6f59eb092
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand-held IPL device (IPL Home Use Hair Removal Device)
• Version Model Number: FZ-100
• Company DUNS: 707411576
• Company Name: Shenzhen IONKA Medical 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: false
• 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	06973071101003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230739

FDA Product Code

• OHT: Light Based Over-The-Counter Hair Removal

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: 2023-08-09
• Device Publish Date: 2023-08-01

On-Brand Devices [Hand-held IPL device (IPL Home Use Hair Removal Device)]

• 06973071106183: IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al
• 06973071106084: IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al
• 06973071102000: IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al
• 06973071101003: IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is al