Ulike

GUDID 16974667826031

IPL 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 Ulike Smart Electronics 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: 16974667826031
• NIH Device Record Key: 00851419-80cc-46df-82fd-32587e85a15c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ulike
• Version Model Number: UI06 PN
• Company DUNS: 618646978
• Company Name: Shenzhen Ulike Smart Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974667826034 [Primary]
GS1	16974667826031 [Package]; Contains: 06974667826034; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223618

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: 2023-03-17
• Device Publish Date: 2023-03-09

On-Brand Devices [Ulike]

• 06974667826010: IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indica
• 16974667826093: UI06 RD
• 16974667826086: UI06 OG
• 06974667826072: UI06 DB
• 16974667826062: UI06 BR
• 16974667826055: UI06 JL
• 06974667826041: UI06 PL
• 16974667826031: IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indica
• 16974667826024: IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indica
• 16974667824143: UI04 SD
• 16974667824044: UI04 DG