ketrina

GUDID 06977638360148

Dongguan Boyuan Intelligent Technology Co.,Ltd

Home-use intense pulsed light hair removal unit

• Primary Device ID: 06977638360148
• NIH Device Record Key: f693ca86-91e0-4f37-8d25-57a0a302f4f5
• Commercial Distribution Discontinuation: 2025-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ketrina
• Version Model Number: KCA450
• Company DUNS: 705002542
• Company Name: Dongguan Boyuan 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: true
• Donation Id Number: true
• 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	06977638360148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240282

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: 2025-02-26
• Device Publish Date: 2025-02-18

On-Brand Devices [ketrina]

• 06977638360537: KFB265
• 06977638360148: KCA450