OMNI

GUDID 04058784001542

Dermatological laser with wavelengths of 755 - 1060 nm. Intended for hair removal (permanent hair reduction) and the treatment of vascular lesions.

Asclepion Laser Technologies GmbH

Dermatological diode laser system

• Primary Device ID: 04058784001542
• NIH Device Record Key: ebd47763-3db8-46b0-b4b9-9c3df51ef071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI
• Version Model Number: O10-0200-000
• 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
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com
• Phone: +4936417700401
• Email: service@asclepion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058784001542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240816

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: 2025-08-18
• Device Publish Date: 2025-08-08

Devices Manufactured by Asclepion Laser Technologies GmbH

• 04058784001542 - OMNI: 2025-08-18Dermatological laser with wavelengths of 755 - 1060 nm. Intended for hair removal (permanent hair reduction) and the treatment of vascular lesions.
• 04058784001542 - OMNI: 2025-08-18 Dermatological laser with wavelengths of 755 - 1060 nm. Intended for hair removal (permanent hair reduction) and the treatment o
• 04058784002037 - MultiCut Blade 350: 2024-12-02 Accessory (Blade) for Morcellator system "MultiCut Solo" Blade with 350 mm length, re-usable
• 04058784002044 - MultiCut Blade 400: 2024-12-02 Accessory (Blade) for Morcellator system "MultiCut Solo" Blade with 400 mm length, re-usable
• 04058784002617 - Dermablate: 2024-11-19 Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue
• 04058784002624 - Dermablate: 2024-11-19 Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue
• 04058784001986 - MultiPulse HoPLUS: 2024-07-03 Holmium Laser for Surgery
• 04058784001115 - MultiCut Solo: 2023-02-27
• 04058784000989 - PicoStar: 2022-06-21 Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo removal and the treatment of be