semlamp

GUDID 06970024710169

IPL hair removal, xenon quartz lamp, with replacement cover.

Shenzhen Semlamp Intelligent Technology Co., Ltd

Home-use intense pulsed light hair removal unit

• Primary Device ID: 06970024710169
• NIH Device Record Key: e45c73e3-473a-4328-bd37-ea9bbb7259e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: semlamp
• Version Model Number: SL-B080
• Company DUNS: 403814543
• Company Name: Shenzhen Semlamp Intelligent 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970024710169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221246

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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [semlamp]

• 06970024710886: IPL hair removal, xenon quartz lamp.
• 06970024710671: IPL hair removal, xenon quartz lamp.
• 06970024710558: IPL hair removal, xenon quartz lamp, can be iced.
• 06970024710374: IPL hair removal, xenon quartz lamp, can be iced.
• 06970024710183: IPL hair removal, xenon quartz lamp.
• 06970024710176: IPL hair removal, xenon quartz lamp.
• 06970024710169: IPL hair removal, xenon quartz lamp, with replacement cover.