Huamei

GUDID 06973512860018

Shandong Huamei Technology Co.,Ltd.

Intense pulsed light skin surface treatment system

• Primary Device ID: 06973512860018
• NIH Device Record Key: d190ecc1-9004-46d8-af66-1fdaa35d47bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huamei
• Version Model Number: IPL-B8
• Company DUNS: 540583132
• Company Name: Shandong Huamei 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: 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	06973512860018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192521

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: 2020-11-06
• Device Publish Date: 2020-10-29

On-Brand Devices [Huamei]

• 06973512860513: HM-C100
• 06973512860414: HM-PL100
• 06973512860315: HM-PDT900
• 06973512860216: HM-CL200
• 06973512860131: HM-DL300
• 06973512860124: HM-DL200
• 06973512860117: HM-DL100
• 06973512860025: IPL-B3
• 06973512860018: IPL-B8
• 06973512860773: HM-EMS900
• 06973512860766: HM-EMS800
• 06973512860759: HM-EMS700
• 06973512860742: HM-EMS600
• 06973512860735: HM-EMS300
• 06973512860728: HM-EMS200
• 06973512860711: HM-EMS100
• 06973512860612: HM-YL900
• 06973512860346: HM-PDT500
• 06973512860339: HM-PDT200
• 06973512860322: HM-PDT100
• 06973512860162: HM-DL600
• 06973512860155: HM-DL900
• 06973512860148: HM-DL800
• 06973512860049: HM-IPL-J2
• 06973512860032: HM-IPL-J1
• 06973512860063: EROSE-YB6
• 06973512860056: EROSE-YA
• 06973512860179: HM-DL220