TattooStar Effect COMBO

GUDID 04058784000064

Dermatological laser with the wavelengths 1064 nm, 532 nm, 585 nm and 694 nm. Intended for the removal of tattoos, pigmented lesions, vascular lesions

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 ID04058784000064
NIH Device Record Keye9df87fa-48c5-481b-9669-43ce13eca841
Commercial Distribution StatusIn Commercial Distribution
Brand NameTattooStar Effect COMBO
Version Model Number1680
Company DUNS332247852
Company NameAsclepion Laser Technologies GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104058784000064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-14

Devices Manufactured by Asclepion Laser Technologies GmbH

04058784001115 - MultiCut Solo2023-02-27
04058784000989 - PicoStar2022-06-21 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 - PicoStar2022-06-21 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 HoPLUS2020-09-02 Holmium Laser for Surgery
04058784001054 - MultiPulse HoPLUS2020-09-02 Holmium Laser for Surgery
04058784000279 - MeDioStar2020-04-06 Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal, permanent hair reduction and the treatment of
04058784000132 - TattooStar2020-02-06
04058784000996 - MultiPulse HoPLUS2019-12-11 Holmium Laser for Surgery

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.