ERISE Laser Handpiece

GUDID 08034108512426

ERISE Laser Handpiece is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The ERISE Laser Handpiece includes: - a connector to connect to the console - a cord where electrical cables and hydraulic tubes pass in - a plastic shell - a laser cavity - a mechanical shutter - an optical guide - an ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm). The 2940nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

DEKA M.E.L.A. SRL

Dermatological solid-state laser system

• Primary Device ID: 08034108512426
• NIH Device Record Key: 8850500f-b8a6-4915-bf54-e2b59c8c736c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERISE Laser Handpiece
• Version Model Number: E262B1
• Company DUNS: 629381096
• Company Name: DEKA M.E.L.A. SRL
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08034108512426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202258

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: 2023-06-26
• Device Publish Date: 2023-06-16

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