Diode Laser Hair Removal

GUDID 06940481500085

Wuhan Lotuxs Technology Co.,Ltd.

Home-use laser epilator

• Primary Device ID: 06940481500085
• NIH Device Record Key: f06af7cf-4f99-4320-bc20-6a13b8112a23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode Laser Hair Removal
• Version Model Number: LHR-V8S-810
• Company DUNS: 421343727
• Company Name: Wuhan Lotuxs 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: true
• 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	06940481500085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230090

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: 2024-09-04
• Device Publish Date: 2024-08-27

On-Brand Devices [Diode Laser Hair Removal]

• 06940481500047: LHR-V4-810
• 06940481500085: LHR-V8S-810
• 06940481500078: LHR-V8-810
• 06940481500061: LHR-V4S-810
• 06940481500221: LHR-V6S/B-1064
• 06940481500207: LHR-V6S-1064