PicoStar

GUDID 04058784000989

Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo removal and the treatment of benign pigmented lesions as well as wrinkles and acne scars.

Asclepion Laser Technologies GmbH

Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 04058784000989
• NIH Device Record Key: d2b69d49-ddbe-460a-b979-55fcd84f0af1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PicoStar
• Version Model Number: M16-9510-000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058784000989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213889

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: 2022-06-21
• Device Publish Date: 2022-06-10

On-Brand Devices [PicoStar]

• 04058784001078: Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo
• 04058784000989: Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo