MCL 31 Dermablate

GUDID 04058784000088

Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).

Asclepion Laser Technologies GmbH

Multi-modality skin surface treatment system generator

• Primary Device ID: 04058784000088
• NIH Device Record Key: ab2cdd55-a957-4416-9809-65e736897383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MCL 31 Dermablate
• Version Model Number: 1821
• Company DUNS: 332247852
• Company Name: Asclepion Laser Technologies GmbH
• 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

Customer Support Contacts

• Phone: +4936417700401
• Email: service@asclepion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058784000088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150140

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-14

On-Brand Devices [MCL 31 Dermablate]

• 04058784000224: Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, abl
• 04058784000088: Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, abl