Tri-Beam Nd:YAG Laser System

GUDID 08800020102010

POWERED LASER SURGICAL INSTRUMENT

Jeisys Medical Inc.

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 08800020102010
• NIH Device Record Key: ca0c1f7f-3237-401c-9263-1154329e8023
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Beam Nd:YAG Laser System
• Version Model Number: TRI-BEAM
• 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	08800020102010 [Primary]
GS1	8800020102034 [Package]; Package: Wooden crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122922

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2021-08-24
• Device Publish Date: 2016-10-31

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