TattooStar R

GUDID 04058784000125

Asclepion Laser Technologies GmbH

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system

• Primary Device ID: 04058784000125
• NIH Device Record Key: 4b963f7b-fade-4f74-98b0-01b6c0604ec8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TattooStar R
• Version Model Number: 1640
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04058784000125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060787

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: 2018-09-24
• Device Publish Date: 2018-08-23

Devices Manufactured by Asclepion Laser Technologies GmbH

• 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
• 04058784001078 - 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
• 04058784001023 - MultiPulse HoPLUS: 2020-09-02 Holmium Laser for Surgery
• 04058784001054 - MultiPulse HoPLUS: 2020-09-02 Holmium Laser for Surgery
• 04058784000279 - MeDioStar: 2020-04-06 Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal, permanent hair reduction and the treatment of
• 04058784000132 - TattooStar: 2020-02-06
• 04058784000996 - MultiPulse HoPLUS: 2019-12-11 Holmium Laser for Surgery