SmoothCool

GUDID 8800020103024

Phototherapy unit

Jeisys Medical Inc.

Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system

• Primary Device ID: 8800020103024
• NIH Device Record Key: 70d97f5b-7268-42aa-9189-830ee525204b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmoothCool
• Version Model Number: SmoothCool
• 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	08800020103017 [Primary]
GS1	8800020103024 [Package]; Contains: 08800020103017; Package: Wooden crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092326

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-19
• Device Publish Date: 2016-10-05

Devices Manufactured by Jeisys Medical Inc.

• 08800020103536 - DENZA Main body: 2023-09-06 Radio-frequency skin contouring system
• 08800020103918 - DENZA B-Tip II: 2023-09-06 DENZA B-Tip II
• 08800020103925 - DENZA B-Tip: 2023-09-06 DENZA B-Tip
• 08800020103932 - DENZA F-Tip II: 2023-09-06 DENZA F-Tip II
• 08800020103949 - DENZA F-Tip: 2023-09-06 DENZA F-Tip
• 08800020103956 - DENZA I-Tip II: 2023-09-06 DENZA I-Tip II
• 08800020103963 - DENZA I-Tip: 2023-09-06 DENZA I-Tip
• 08800020103970 - DENZA Handpiece: 2023-09-06 Radio-frequency skin contouring system