Intense Pulsed Light (IPL) System

GUDID 06971008271072

Shenzhen Fansizhe Science And Technology Co., Ltd.

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• Primary Device ID: 06971008271072
• NIH Device Record Key: bec804b5-6198-4cd2-97bd-aa622725a2e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intense Pulsed Light (IPL) System
• Version Model Number: T015A
• Company DUNS: 417663470
• Company Name: Shenzhen Fansizhe Science And 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971008271072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221569

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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: 2023-04-17
• Device Publish Date: 2023-04-07

On-Brand Devices [Intense Pulsed Light (IPL) System]

• 06971008271065: T015K
• 06971008271058: T015C
• 06971008271041: T013C
• 06971008271034: T012C
• 06971008271072: T015A
• 06971008271218: T016K
• 06971008271201: T011C
• 06971008271195: T001N
• 06971008271188: T001B
• 06971008271171: T001M
• 06971008271164: T001A
• 06971008271157: T021A
• 06971008271140: T021K
• 06971008271133: T023E
• 06971008271126: T023D
• 06971008271119: T023C
• 06971008271102: T023B
• 06971008271096: T023A
• 06971008271089: T023K
• 06971008271249: T033KW
• 06971008271232: T002BW
• 06971008271225: T002AW