MediDiode

GUDID 00860009525122

MEDICREATIONS LLC

Dermatological diode laser system

• Primary Device ID: 00860009525122
• NIH Device Record Key: 2958df11-7c83-45c1-a5f6-ca431dd14a9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediDiode
• Version Model Number: 2.0
• Company DUNS: 106075496
• Company Name: MEDICREATIONS LLC
• 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	00860009525122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231950

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: 2026-02-19
• Device Publish Date: 2026-02-11

Devices Manufactured by MEDICREATIONS LLC

• 00860009525108 - MediSpa: 2026-02-19
• 00860009525115 - MediYag: 2026-02-19
• 00860009525122 - MediDiode: 2026-02-19
• 00860009525122 - MediDiode: 2026-02-19
• 00860009525146 - MediLight: 2026-02-19