SmoothCool HR

GUDID 08800020102720

Unit (FDA)

Jeisys Medical Inc.

Intense pulsed light skin surface treatment system

• Primary Device ID: 08800020102720
• NIH Device Record Key: e66a3790-f7eb-4f69-849d-996197592992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmoothCool HR
• Version Model Number: SmoothCool HR
• Company DUNS: 690275362
• Company Name: Jeisys Medical Inc.
• 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	08800020102720 [Package]; Contains: 08800020102737; Package: wooden crate [1 Units]; In Commercial Distribution
GS1	08800020102737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213484

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [SmoothCool HR]

• 08800020106018: Phototherapy unit
• 08800020102720: Unit (FDA)